Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft

NCT05107141 | Completed FDA Device

• 1 other identifier: 2013-M-PER-ECL-2013-04
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.

Conditions

Alveolar Ridge Preservation

Keywords

alveolar ridge preservation; molars; xenograft; allograft

Outcome Measures

Primary Outcomes (1)

• Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.

  To evaluate dimensional changes, the initial (CBCT1) and 5 months (CBCT2) CBCT images were processed and superimposed with the use of a specialized software image Simplant® O\&O (Denstply Sirona, Charlotte, NC, USA). Measurements were expressed in millimeters (mm) and percentages showing changes in ridge width at 1mm, 3mm and 5mm from the bone crest. The height of the buccal, and lingual bone crest was assessed, as well as the heigh in the central are of the socket.

  5 months

Secondary Outcomes (2)

• Evaluate the influence of buccal or lingual bone thickness on bone ridge changes

  5 months

• Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.

  5 months

Study Arms (2)

xenograft and a collagen membrane

ACTIVE COMPARATOR

Procedure: Ridge preservation; Device: bone graft plus a collagen membrane

allograft and a collagen membrane

ACTIVE COMPARATOR

Procedure: Ridge preservation; Device: bone graft plus a collagen membrane

Interventions

Ridge preservation PROCEDURE

Ridge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane

allograft and a collagen membrane; xenograft and a collagen membrane

bone graft plus a collagen membrane DEVICE

allograft and a collagen membrane; xenograft and a collagen membrane

Eligibility Criteria

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

You may qualify if:

• Adult patients, over 18 years old.
• In need of removal of a maxillary or mandibular molar first or second molar.
• The molars to be extracted had to be bordered by at least one tooth.
• The molars had to have a presence of \> 2 mm of keratinized gingiva and three intact bony walls.
• A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
• Only one extraction per patient was accepted.

You may not qualify if:

• Acute periodontal or periapical infection.
• Pregnancy or lactancy.
• Smokers of more than 10 cigarettes per day.
• Previous adverse reactions to the biomaterials used in the study.
• Metabolic diseases affecting the mechanism of bone remodelling.
• Medications or treatments taken in the last twelve months and known to affect bone "turnover".
• Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
• Patients with absence of periodontal health maintenance or postoperative recommendations compliance.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• BioHorizons, Inc.: collaborator
• Geistlich Pharma AG: collaborator
• Dentsply Sirona Implants and Consumables: collaborator

Related Publications (5)

• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 BACKGROUND

• Nart J, Barallat L, Jimenez D, Mestres J, Gomez A, Carrasco MA, Violant D, Ruiz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin Oral Implants Res. 2017 Jul;28(7):840-848. doi: 10.1111/clr.12889. Epub 2016 Jun 22.

  PMID: 27335267 BACKGROUND

• Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.

  PMID: 31215112 BACKGROUND

• Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.

  PMID: 27788625 BACKGROUND

• Duong M, Mealey BL, Walker C, Al-Harthi S, Prihoda TJ, Huynh-Ba G. Evaluation of healing at molar extraction sites with and without ridge preservation: A three-arm histologic analysis. J Periodontol. 2020 Jan;91(1):74-82. doi: 10.1002/JPER.19-0237. Epub 2019 Aug 11.

  PMID: 31355447 BACKGROUND

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Jose Nart Molina

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: November 4, 2021
• Study Start: December 9, 2013
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share