Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

Not Applicable

Completed

• Conditions: Ridge Preservation; Bone Regeneration

• Registration Number: NCT03497403
• Lead Sponsor: Harvard School of Dental Medicine

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.

Study Timeline

• Study Start: 2016-10-18
• Primary Completion: 2017-04-19
• Study Completion: 2017-09-29
• Status Verified: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-11
• Last Update Submitted: 2018-04-11
• Study First Posted: 2018-04-13
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. between 20-80 years of age
2. healthy with no conditions that could alter wound healing
3. requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
4. a tooth requiring extraction that is treatment planned for implant placement
5. willing to participate in the study and sign the informed consent
6. willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.

Exclusion Criteria

1. systemic conditions which could alter wound healing
2. tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
3. severe local infection at extraction site
4. a tooth exhibiting severe resorption of buccal or lingual plates
5. absence of keratinized tissue buccal to the tooth to be extracted
6. severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Keratinized tissue width	6 months	Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.

Secondary Outcome Measures

Name	Time	Method
Keratinized tissue thickness	6 months	Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.
CEJ-FGM	6 months	The distance from the tooth's cervical enamel junction (CEJ) to the free gingival margin (FGM) was taken with a probe.
Ridge Width	6 months	After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.
Cast ridge width	6 months	Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers.
Cast ridge volume	6 months	Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner.
Vestibular Depth	6 months	The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.
CEJ- Buccal crest	6 months	The distance from the tooth's cervical enamel junction and the top of the buccal bone crest was taken with a probe.
CBCT bone height	6 months	CBCT scans were taken and the alveolar ridge height was then measured.
CBCT bone width	6 months	CBCT scans were taken and the alveolar ridge width was then measured.

Trial Locations

Locations (1)

Harvard School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States