Procedures for Improving the Mucosa Around Implants

Summary

This research study is looking at three different procedures for improving the oral mucosa (membrane) around dental implants. The three procedures will be the standard procedure, the standard procedure with the use of tissue harvested from the mouth and the standard procedure with the use of Mucograft membrane product. An advantage claimed by the Mucograft manufacturer is increased patient comfort due to lack of tissue harvesting from the mouth. Pain and discomfort levels will be evaluated for each of the procedures. Gain in oral mucosa and the visual will also be evaluated.

Conditions

• Keratinized Mucosa
• Dental Implants

Interventions

PROCEDURE

Apically positioned flap

Standard TUSDM Periodontology Clinic procedures will be followed. Local anesthesia will be achieved. Center of implant fixtures will be located. Crestal incision thru the center of implant fixture will be made. Implant fixture will be uncovered and healing abutment/s will be inserted. Horizontal incision at approximately 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area. No vertical incision will be made Gingiva coronal to horizontal incision will remain intact Partial thickness flap will be prepared and displaced apically approximately 7mm from the horizontal incision and secured with sutures. Prepared surgical area will be measured apico-coronally and mesio-distally.

PROCEDURE

Free Gingival Graft

Standard Clinic procedures followed. Local anesthesia achieved. Center of implant fixtures located. Crestal incision thru center of fixture will be made. Implant fixture uncovered and healing abutment/s inserted. Horizontal incision at approx 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area. No vertical incision made. Gingiva coronal to horizontal incision remains intact. Partial thickness flap prepared and displaced apically approximately 7mm from horizontal incision; secured with sutures. Prepared recipient bed measured apico-coronally and mesio-distally. Masticatory mucosa from palate of treating side (Right or Left) harvested according to size measured from recipient bed with width of approximately 5mm at line of measurement. Harvested graft material will be transplanted on recipient bed, lined with initial horizontal incision line with sutures

PROCEDURE

apically positioned flap with Mucograft

Standard TUSDM Periodontology Clinic procedures followed. Local anesthesia achieved. Center of implant fixtures will be located. Crestal incision thru the center of implant fixture will be made. Implant fixture will be uncovered and healing abutment/s will be inserted. Horizontal incision at approximately 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area. No vertical incision will be made. Gingiva coronal to horizontal incision will remain intact. Partial thickness flap will be prepared and displaced apically approximately 7mm from the horizontal incision and secured with sutures. Prepared recipient bed will be measured apico-coronally and mesio-distally. Mucograft material will be prepared according to the manufacturer's instruction and trimmed as the size measured from the recipient and be placed and secured on the recipient bed with sutures.

Sponsors & Collaborators

• Tufts University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2014-05-31

Completion

2016-05-31

Countries

• United States

Study Locations