Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
Time Frame: 3 months
Percentage of vital bone
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months
Time Frame: 6 months
Percentage of vital bone
Secondary Outcomes
- Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months)(3 months)
- Patient reported outcomes (number of days of total or partially impaired activity) following implant placement(4 months post implant placement)
- Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)(6 months)
- Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)(2 weeks following tooth extraction and alveolar ridge preservation)
- Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating)(2 weeks after dental implant placement)
- Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction(At the time of implant placement (3 or 6 months))
- Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)(2 weeks following tooth extraction and alveolar ridge preservation)
- Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)(Up to 30 days post implant crown delivery)
- Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)(3 months following tooth extraction and alveolar ridge preservation)
- Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)(6 months following tooth extraction and alveolar ridge preservation)
- Implant survival rate(1 year post implant loading)
- Marginal bone level changes(1 year post implant loading)