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

NCT ID: NCT05107141

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-09

Study Completion Date

2019-06-07

Brief Summary

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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

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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.

Conditions

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Alveolar Ridge Preservation

Keywords

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alveolar ridge preservation molars xenograft allograft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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xenograft and a collagen membrane

Group Type ACTIVE_COMPARATOR

Ridge preservation

Intervention Type PROCEDURE

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

bone graft plus a collagen membrane

Intervention Type DEVICE

allograft and a collagen membrane

Group Type ACTIVE_COMPARATOR

Ridge preservation

Intervention Type PROCEDURE

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

bone graft plus a collagen membrane

Intervention Type DEVICE

Interventions

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Ridge preservation

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

Intervention Type PROCEDURE

bone graft plus a collagen membrane

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioHorizons, Inc.

INDUSTRY

Sponsor Role collaborator

Geistlich Pharma AG

INDUSTRY

Sponsor Role collaborator

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Desire Abellán Iñiguez

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Nart Molina

Role: STUDY_DIRECTOR

Universitat Internacional de Catalunya

References

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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.

Reference Type BACKGROUND
PMID: 30623987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27335267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31215112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27788625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31355447 (View on PubMed)

Other Identifiers

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2013-M-PER-ECL-2013-04

Identifier Type: -

Identifier Source: org_study_id