Alveolar Ridge Preservation Procedures

NCT05419778 | Completed

• 1 other identifier: 18-06428-FB
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Tooth loss is accompanied by different patterns of bone loss. Up to 50% loss of alveolar crestal bone width will likely occur 1 year after tooth loss, especially in the anterior maxilla. A great percentage of the process of alveolar bone resorption occurs within the first 3 to 6 months post-extraction. If ridge preservation is not conducted, 40%-60% of the total alveolar bone volume is lost during the first 2-3 years post-extraction, and this phenomenon has shown to continue to occur at a rate of 0.25%-0.5% loss per year. It has been proposed that ridge augmentation procedures may reduce the expected ridge reduction after tooth loss. Ridge augmentation procedures may require the use of bone grafts and non-resorbable or non-resorbable barrier membranes. The use of non-resorbable barrier membranes for ridge augmentation has the clinical disadvantage of needing a second procedure for its removal during the healing phase. Osteogen® plug (OPP) consists of a non-ceramic bone graft incorporated in type I bovine Achilles tendon collagen. OPP was first developed to serve as a one-step grafting solution for ridge preservation without the need for a barrier membrane

Conditions

Alveolar Ridge Preservation

Keywords

Bone; OsteoGen; Cortico-Cancellous; Foreign body reaction

Outcome Measures

Primary Outcomes (7)

• Histological Bone Formation Changes

  histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone

  4 weeks

• Histological Bone Formation Changes

  histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone

  6 weeks

• Histological Bone Formation Changes

  histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone

  20 weeks

• Clinical Dimensional Changes

  * Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography. * Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0.

  4 weeks

• Clinical Dimensional Changes

  * Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography. * Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0.

  6 weeks

• Clinical Dimensional Changes

  * Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography. * Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0.

  20 weeks

• Evaluate Patient Pain

  Evaluate patient pain during the wound healing phase using the visual analog scale (VAS). Scale range (0-10) : 0 1 2 3 4 5 6 7 8 9 10 Minimum Value: 0 = no pain Maximum Value: 10 = worse pain ever imaged

  20 weeks

Study Arms (2)

Group A (Osteogen plug®)

The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation. The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to receive treatment with a type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)(Osteogen) ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 4-6 weeks and again at 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area.

Device: Osteogen plug®

Group B ( MInerOss® )

The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation. The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to a cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 4-6 weeks and again at 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area.

Device: MInerOss®

Interventions

Osteogen plug® DEVICE

A type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)

Group A (Osteogen plug®)

MInerOss® DEVICE

A cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane.

Group B ( MInerOss® )

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to twenty (20) participants, at least 12 years old, needing a tooth (teeth) extraction(s) with a combined extraction site preservation treatment of 20 extraction sites.

You may qualify if:

• UT Clinic Participates
• Participates that live within 100 miles of UTHSC.
• Participates at least 12 years of age. If participants are 13-14 years of age, the premolars and molars will be included in this study. #2-15 \& #18-31.
• Participates willing to cooperate with the post-operative instructions;
• Participates with 2 or more (multiples of 2) teeth needing Maxillary/mandibular and anterior/posterior teeth extractions without restrictions due to the percentage of surface area after the extraction and not interfering with the tooth's alveolar soft tissue exposed surface area.
• Participates with the availability of returning for 8 visits for data collection.
• Participants are willing to cooperate with answering the VAS and taking standardized photographs.
• Participants are physically able to tolerate surgical procedures based on current medical history.
• Participates able to provide voluntary consent; read and understand English

You may not qualify if:

• Participates with Diabetes
• History of use of bisphosphonates
• Current smoker
• If the participant is 12-13 years of age, the tooth/teeth to be removed will not be a primary tooth due to the permanent teeth developing underneath the primary teeth.
• Pregnant and lactating women

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (18)

• Molnar JA, Lew WK, Rapp DA, Gordon ES, Voignier D, Rushing S, Willner W. Use of standardized, quantitative digital photography in a multicenter Web-based study. Eplasty. 2009;9:e4. Epub 2009 Jan 12.

  PMID: 19212431 BACKGROUND

• McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.

  PMID: 3078045 BACKGROUND

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  PMID: 12956475 BACKGROUND

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 BACKGROUND

• Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.

  PMID: 16515093 BACKGROUND

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  PMID: 12806317 BACKGROUND

• Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. doi: 10.1097/00008505-200009020-00011.

  PMID: 11307396 BACKGROUND

• Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x.

  PMID: 19419446 BACKGROUND

• Barber HD, Lignelli J, Smith BM, Bartee BK. Using a dense PTFE membrane without primary closure to achieve bone and tissue regeneration. J Oral Maxillofac Surg. 2007 Apr;65(4):748-52. doi: 10.1016/j.joms.2006.10.042.

  PMID: 17368373 BACKGROUND

• Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.

  PMID: 9776033 BACKGROUND

• Wang HL, Boyapati L. "PASS" principles for predictable bone regeneration. Implant Dent. 2006 Mar;15(1):8-17. doi: 10.1097/01.id.0000204762.39826.0f.

  PMID: 16569956 BACKGROUND

• Kosinski T. A Simple and Cost-Effective Socket Preservation Technique. Dent Today. 2016 Apr;35(4):90, 92, 94-5. No abstract available.

  PMID: 27244995 BACKGROUND

• Feng L, Zhang L, Cui Y, Song TX, Qiu ZY, Wang XM, Tan BS. Clinical evaluations of mineralized collagen in the extraction sites preservation. Regen Biomater. 2016 Mar;3(1):41-8. doi: 10.1093/rb/rbv027. Epub 2016 Jan 19.

  PMID: 26815224 BACKGROUND

• Nevins M, Parma-Benfenati S, Janke UW, Kleyer A, Rasperini G, Tinti C, Schupbach P, Kim DM. The efficacy of mineralized allograft cortical and cancellous chips in maxillary sinus augmentations. Int J Periodontics Restorative Dent. 2014 Nov-Dec;34(6):789-93. doi: 10.11607/prd.1720.

  PMID: 25411734 BACKGROUND

• Park JC, Koo KT, Lim HC. The hidden X suture: a technical note on a novel suture technique for alveolar ridge preservation. J Periodontal Implant Sci. 2016 Dec;46(6):415-425. doi: 10.5051/jpis.2016.46.6.415. Epub 2016 Dec 26.

  PMID: 28050319 BACKGROUND

• Evian CI, Rosenberg ES, Coslet JG, Corn H. The osteogenic activity of bone removed from healing extraction sockets in humans. J Periodontol. 1982 Feb;53(2):81-5. doi: 10.1902/jop.1982.53.2.81.

  PMID: 6950085 RESULT

• Dahlin C, Linde A, Gottlow J, Nyman S. Healing of bone defects by guided tissue regeneration. Plast Reconstr Surg. 1988 May;81(5):672-6. doi: 10.1097/00006534-198805000-00004.

  PMID: 3362985 RESULT

• Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2017 Oct 6;10(10):CD012432. doi: 10.1002/14651858.CD012432.pub2.

  PMID: 28983908 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess tissue will be collected if the subject has a standard of care implant-related procedure where tissue could need to be removed for implant placement purposes. For example, if a patient undergoes a tooth extraction, ridge augmentation, and implant placement then any portion of the excised tooth and connective tissue will be kept for later analyses of histology discovery.

MeSH Terms

Conditions

Foreign-Body Reaction

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign Bodies; Wounds and Injuries

Study Officials

• Cimara F Ferreira, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 15, 2022
• Study Start: February 8, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 11, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-05

Locations

US (1)