Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

Bone Regeneration Clinical Trial

Official title:

Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497403
• Other study ID #: IRB15-3772
• Status: Completed
• Phase: N/A
• First received: April 5, 2018
• Last updated: April 11, 2018
• Start date: October 18, 2016
• Est. completion date: September 29, 2017

Study information

• Verified date: April 2018
• Source: Harvard School of Dental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 29, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Regeneration
• Ridge Preservation

Intervention

Procedure:
• Socket preservation control
After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
• Socket preservation experimental
After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Dental Medicine	Valeant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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