Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ridge Preservation
- Sponsor
- Harvard School of Dental Medicine
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Keratinized tissue width
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.
Detailed Description
The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline \& 6-months.
Investigators
Heather Hong
Principle Investigator
Harvard School of Dental Medicine
Eligibility Criteria
Inclusion Criteria
- •between 20-80 years of age
- •healthy with no conditions that could alter wound healing
- •requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
- •a tooth requiring extraction that is treatment planned for implant placement
- •willing to participate in the study and sign the informed consent
- •willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.
Exclusion Criteria
- •systemic conditions which could alter wound healing
- •tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
- •severe local infection at extraction site
- •a tooth exhibiting severe resorption of buccal or lingual plates
- •absence of keratinized tissue buccal to the tooth to be extracted
- •severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.
Outcomes
Primary Outcomes
Keratinized tissue width
Time Frame: 6 months
Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.
Secondary Outcomes
- Keratinized tissue thickness(6 months)
- CEJ-FGM(6 months)
- Ridge Width(6 months)
- Cast ridge width(6 months)
- Cast ridge volume(6 months)
- Vestibular Depth(6 months)
- CEJ- Buccal crest(6 months)
- CBCT bone height(6 months)
- CBCT bone width(6 months)