Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Regeneration; Ridge Preservation
• Intervention / Treatment: Procedure: Socket preservation control; Procedure: Socket preservation experimental

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing.	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.
Experimental: Experimental; Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized tissue width	Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized tissue thickness	Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.	6 months
Vestibular Depth	The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.	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.	6 months
Ridge Width	After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.	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.	6 months
CBCT bone height	CBCT scans were taken and the alveolar ridge height was then measured.	6 months
CBCT bone width	CBCT scans were taken and the alveolar ridge width was then measured.	6 months
Cast ridge width	Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers.	6 months
Cast ridge volume	Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner.	6 months

Collaborators and Investigators

• Sponsor: Harvard School of Dental Medicine
• Collaborators: Valeant Pharmaceuticals
• Investigators: Principal Investigator: Eli Machtei, DMD, Harvard School of Dental Med.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): April 19, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB15-3772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No