Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets

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

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2029-12-31

Brief Summary

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The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is:

Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets.

Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement.

Participants will:

Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure.

Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material.

Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement.

Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.

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Detailed Description

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Conditions

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Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implant placement 3 months after tooth extraction

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 3 months after tooth extraction

Group Type EXPERIMENTAL

Alveolar ridge preservation

Intervention Type PROCEDURE

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)

Implant placement 6 months after tooth extraction

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 6 months after tooth extraction

Group Type ACTIVE_COMPARATOR

Alveolar ridge preservation

Intervention Type PROCEDURE

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)

Interventions

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Alveolar ridge preservation

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* ASA (American Society of Anesthesia) status I or II
* Need for molar extraction due to periodontal disease with or without chronic endodontic involvement, complying with the presentation of periodontitis stage III/IV
* Radiographic evidence of a bone dehiscence on at least one socket wall, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is \>50% of the corresponding root length as measured on CBCT scans prior to extraction (Ben Amara et al., 2021)
* Radiographic evidence of at least 3 mm of residual bone wall height
* Presence of at least one adjacent tooth to the extraction site
* Treatment plan must include tooth replacement with an implant-supported fixed dental prosthesis

Exclusion Criteria

* Extraction of multiple adjacent teeth
* Acute infection associated with the tooth to be extracted or with adjacent teeth
* Current smokers (\>10 cigarettes per day)
* Uncontrolled diabetes mellitus (HbA1c \>7.0)
* Any active oral or systemic acute infections
* Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
* Diseases or medications that may compromise normal wound healing

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No