Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

Harvard School of Dental Medicine30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ridge Preservation Bone Regeneration

Interventions

Socket preservation controlPROCEDURE

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 experimentalPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Harvard School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Keratinized tissue width

Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.

Time frame: 6 months

Secondary Outcomes

Keratinized tissue thickness

Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.

Time frame: 6 months

Vestibular Depth

The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.

Time frame: 6 months

CEJ-FGM

The distance from the tooth's cervical enamel junction (CEJ) to the free gingival margin (FGM) was taken with a probe.

Time frame: 6 months

Ridge Width

After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.

Time frame: 6 months

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.

Time frame: 6 months

CBCT bone height

CBCT scans were taken and the alveolar ridge height was then measured.

Time frame: 6 months

CBCT bone width

CBCT scans were taken and the alveolar ridge width was then measured.

Time frame: 6 months

Data from ClinicalTrials.gov

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