mp3 vs Apatos in Post-extractive Sockets

NCT02644070 | Completed

• 1 other identifier: 214 in June 14, 2012
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of the present multicenter randomized controlled trial was to evaluate and compare the shortterm clinical and histological changes of extraction sockets after ridge preservation procedures with changes of extraction sockets that healed naturally. The secondary aim was to evaluate which, if any extraction socket characteristics could have affected tissue changes occurring at the augmented as well as naturally healed sites. Recruitment and enrollment of patients were performed from June 2011 to June 2012 in five university centers/private practice:

• University of Pisa;
• University of Murcia;
• University of Ancona;
• Private practice, Dr. Di Felice;
• University of Verona. Randomization:
• extraction sockets with spontaneous healing;
• extraction sockets grafted with pre-hydrated collagenated cortico-cancellous porcine bone, with a particle size between 600 and 1000 μm;
• extraction sockets grafted with cortical porcine bone, with a particle size between 600 and 1000 μm.
• Complications
• Changes of ridge volume contour;
• Vertical bone changes;
• Buccal-Lingual Width;
• Histomorphometric parameters. Sample size was calculated comparing outcome data between grafted sockets versus non-grafted sockets. The primary parameter was the change in mid-buccal vertical height (0.7±1.4mm and 3.6±1.5mm, respectively, for the test and control groups) (Barone et al. 2008). Final sample size was increased to 30 subjects per group due to possible patient dropout events. Each center contributed according to the predetermined 1:1:1 ratio; the fresh extraction socket was considered the unit of randomization. Corrections for balancing the three experimental groups for confounding factors were not applied. A matrix elaborator performed all the analyses§§: multi-way analysis of variance (ANOVAn) was applied, then appropriate post hoc comparison tests were run; post hoc estimated effect sizes were calculated with a power of 0.9. The level of statistical significance was set at 0.05 for all analyses.

Conditions

Alveolar Bone Loss

Keywords

Alveolar bone loss; Alveoloplasty; Bone remodeling; Xenograft; Tooth socket; Dental implant

Outcome Measures

Primary Outcomes (24)

• Clinical vertical bone changes

  Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.

  0 months after grafting

• Clinical vertical bone changes

  Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.

  1 month after grafting

• Clinical vertical bone changes

  Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.

  3 months after grafting

• Clinical vertical bone changes

  Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.

  12 months after grafting

• Clinical vertical bone changes

  Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.

  24 months after grafting

• Clinical vertical bone changes

  Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.

  36 months after grafting

• Volume of the alveolar ridge

  Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.

  0 months after grafting

• Volume of the alveolar ridge

  Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.

  1 month after grafting

• Volume of the alveolar ridge

  Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.

  3 months after grafting

• Volume of the alveolar ridge

  Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.

  12 months after grafting

• Volume of the alveolar ridge

  Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.

  24 months after grafting

• Volume of the alveolar ridge

  Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.

  36 months after grafting

• Buccal-Lingual Width

  Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseline value from the post-operative value.

  0 months after grafting

• Buccal-Lingual Width

  Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseline value from the post-operative value.

  1 month after grafting

• Buccal-Lingual Width

  Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseline value from the post-operative value.

  3 months after grafting

• Buccal-Lingual Width

  Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseline value from the post-operative value.

  12 months after grafting

• Buccal-Lingual Width

  Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseline value from the post-operative value.

  24 months after grafting

• Buccal-Lingual Width

  Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseline value from the post-operative value.

  36 months after grafting

• Marginal bone loss

  Bone loss was measured (in mm) by comparing the radiographs taken at baseline (immediately after placement) to the postoperative ones. The marginal bone height (MBL) was measured as the distance between the reference point (fixture-abutment interface) and the most apical point of the marginal bone level. Calibration was performed using the known thread-pitch distance of the implants (pitch = 1.0 mm), and fixture diameter and length.

  12 months after grafting

• Marginal bone loss

  Bone loss was measured (in mm) by comparing the radiographs taken at baseline (immediately after placement) to the postoperative ones. The marginal bone height (MBL) was measured as the distance between the reference point (fixture-abutment interface) and the most apical point of the marginal bone level. Calibration was performed using the known thread-pitch distance of the implants (pitch = 1.0 mm), and fixture diameter and length.

  24 months after grafting

• Marginal bone loss

  Bone loss was measured (in mm) by comparing the radiographs taken at baseline (immediately after placement) to the postoperative ones. The marginal bone height (MBL) was measured as the distance between the reference point (fixture-abutment interface) and the most apical point of the marginal bone level. Calibration was performed using the known thread-pitch distance of the implants (pitch = 1.0 mm), and fixture diameter and length.

  36 months after grafting

• Implant success

  Implant failure (count) was defined as implant mobility, removal of implants caused by progressive bone loss or infection. The stability of each implant was evaluated at the delivery of prosthetic restoration and 1 year after implant insertion and two metallic handles of dental instruments were used to evaluate the stability of single crowns. Success rates (in percentage) were calculated according to the criteria suggested by Buser and colleagues.

  12, 24, 36 months after grafting

• Implant success

  Implant failure (count) was defined as implant mobility, removal of implants caused by progressive bone loss or infection. The stability of each implant was evaluated at the delivery of prosthetic restoration and 1 year after implant insertion and two metallic handles of dental instruments were used to evaluate the stability of single crowns. Success rates (in percentage) were calculated according to the criteria suggested by Buser and colleagues.

  24 months after grafting

• Implant success

  Implant failure (count) was defined as implant mobility, removal of implants caused by progressive bone loss or infection. The stability of each implant was evaluated at the delivery of prosthetic restoration and 1 year after implant insertion and two metallic handles of dental instruments were used to evaluate the stability of single crowns. Success rates (in percentage) were calculated according to the criteria suggested by Buser and colleagues.

  36 months after grafting

Secondary Outcomes (15)

• NFB: newly formed bone

  3 months after extraction procedure

• RGP: residual graft particle

  3 months after extraction procedure

• NMT: non-mineralized tissue

  3 months after extraction procedure

• Facial Soft Tissue Level

  12 months after grafting

• Facial Soft Tissue Level

  24 months after grafting

Study Arms (3)

alveolar bone preservation with mp3

EXPERIMENTAL

Extraction sockets grafted with corticocancellous porcine bone and collagen (MP3, Osteobiol, Coazze, Italy) with graft particle size between 600 and 1000 µm and a collagen membrane (Evolution, Osteobiol, Coazze, Italy) used to stabilize the biomaterial into the socket.

Device: alveolar bone preservation with mp3; Device: stabilization with membrane

alveolar bone preservation with apatos

EXPERIMENTAL

Extraction sockets grafted with cortical porcine bone with particle size between 600 and 1000 µm (Apatos, Osteobiol, Coazze, Italy ) and a collagen membrane (Evolution, Osteobiol, Coazze, Italy) used to stabilize the biomaterial into the socket.

Device: alveolar bone preservation with apatos; Device: stabilization with membrane

NO_graft

NO INTERVENTION

extraction sockets with spontaneous healing

Interventions

alveolar bone preservation with mp3 DEVICE

graft with corticocancellous porcine bone and collagen (MP3, Osteobiol, Coazze, Italy)

alveolar bone preservation with mp3

alveolar bone preservation with apatos DEVICE

graft with cortical porcine bone (Apatos, Osteobiol, Coazze, Italy )

alveolar bone preservation with apatos

stabilization with membrane DEVICE

socket stabilization with a collagen membrane (Evolution, Osteobiol, Coazze, Italy)

alveolar bone preservation with apatos; alveolar bone preservation with mp3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• requiring one single tooth extraction and subsequently an implant-supported restoration
• able to sign an informed consent form

You may not qualify if:

• history of systemic diseases that would contraindicate oral surgical treatment;
• long-term non-steroidal anti-inflammatory drug therapy;
• lack of opposite occluding dentition in the area intended for extraction and subsequent implant placement;
• Oral biphosphonate therapy;
• absence of adjacent teeth;
• unwillingness to return for the follow-up examination;
• use of more than 10 cigarettes per day. Subjects smoking less than 10 cigarettes per day were requested to stop smoking before and after surgery; however, their compliance could not be monitored.

Sponsors & Collaborators

• Tuscan Dental Institute: lead

Related Publications (6)

• Barone A, Borgia V, Covani U, Ricci M, Piattelli A, Iezzi G. Flap versus flapless procedure for ridge preservation in alveolar extraction sockets: a histological evaluation in a randomized clinical trial. Clin Oral Implants Res. 2015 Jul;26(7):806-13. doi: 10.1111/clr.12358. Epub 2014 Mar 1.

  PMID: 24580835 BACKGROUND

• Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.

  PMID: 18672985 BACKGROUND

• Barone A, Ricci M, Tonelli P, Santini S, Covani U. Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing. Clin Oral Implants Res. 2013 Nov;24(11):1231-7. doi: 10.1111/j.1600-0501.2012.02535.x. Epub 2012 Jul 12.

  PMID: 22784417 BACKGROUND

• Covani U, Ricci M, Bozzolo G, Mangano F, Zini A, Barone A. Analysis of the pattern of the alveolar ridge remodelling following single tooth extraction. Clin Oral Implants Res. 2011 Aug;22(8):820-5. doi: 10.1111/j.1600-0501.2010.02060.x. Epub 2010 Dec 29.

  PMID: 21198897 BACKGROUND

• Engler-Hamm D, Cheung WS, Yen A, Stark PC, Griffin T. Ridge preservation using a composite bone graft and a bioabsorbable membrane with and without primary wound closure: a comparative clinical trial. J Periodontol. 2011 Mar;82(3):377-87. doi: 10.1902/jop.2010.090342. Epub 2010 Nov 2.

  PMID: 21043792 BACKGROUND

• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

  PMID: 12956475 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Antonio Barone, DDS, PhD, MSc, University of Pisa Adjunct Professor

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 31, 2015
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 15, 2023

Record last verified: 2023-05