Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

NCT03497403 | Completed

• 1 other identifier: IRB15-3772
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Preservation; Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• Keratinized tissue width

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

  6 months

Secondary Outcomes (9)

• Keratinized tissue thickness

  6 months

• Vestibular Depth

  6 months

• CEJ-FGM

  6 months

• Ridge Width

  6 months

• CEJ- Buccal crest

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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

Interventions

Socket preservation control PROCEDURE

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.

Control

Socket preservation experimental PROCEDURE

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.

Experimental

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harvard School of Dental Medicine: lead
• Valeant Pharmaceuticals: collaborator

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Eli Machtei, DMD

  Harvard School of Dental Med.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants were assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 13, 2018
• Study Start: October 18, 2016
• Primary Completion: April 19, 2017
• Study Completion: September 29, 2017
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)