Clinical trial NCT05107141: Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft
Official title: Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Preservation
Keywords: alveolar ridge preservation
molars
xenograft
allograft
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
name: Geistlich Pharma AG
name: Dentsply Sirona Implants and Consumables
First posted: 2021-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 5 months
Secondary outcomes:
measure: Evaluate the influence of buccal or lingual bone thickness on bone ridge changes
timeFrame: 5 months
measure: Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Jose Nart Molina
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.