Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

Harvard School of Dental Medicine

Status: Completed

Conditions: Bone Regeneration; Ridge Preservation

Treatments: Procedure: Socket preservation experimental; Procedure: Socket preservation control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03497403

IRB15-3772

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control

Active Comparator group

Description:

Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing.

Treatment:

Procedure: Socket preservation control

Experimental

Experimental group

Description:

Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing.

Treatment:

Procedure: Socket preservation experimental