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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Tooth Loss

Treatments: Procedure: Alveolar ridge preservation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06654141

SDC-2024-1

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

Implant placement 3 months after tooth extraction

Experimental group

Description:

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

Treatment:

Procedure: Alveolar ridge preservation

Implant placement 6 months after tooth extraction

Active Comparator group

Description:

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

Treatment:

Procedure: Alveolar ridge preservation