Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase
Not applicable
Started
2025-02-06
Last updated
2025-02-19
Condition(s) studied
Tooth Loss
Investigational drug(s) / intervention(s)
Alveolar ridge preservation
Alveolar ridge preservation: Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months — 3 months Percentage of vital bone
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months — 6 months Percentage of vital bone
Trial sites (1)
Facility
City
Region
Status
Shanghai Ninth People's Hospital
Shanghai
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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