Procedures for Improving the Mucosa Around Implants

NCT01944267 | Completed

• 1 other identifier: IRB 10893
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain and discomfort survey

  A survey using VAS scale will be performed from the subjects at 10-14 days follow up visit.

  10 to 14 days follow up

Secondary Outcomes (1)

• Evaluation of full mouth gingival condition (periodontal parameters)

  At 3-month and 6-month follow up appointments.

Study Arms (3)

Apically positioned flap

ACTIVE COMPARATOR

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: Apically positioned flap

Free Gingival Graft

ACTIVE COMPARATOR

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: Free Gingival Graft

Apically positioned flap with Mucograft

ACTIVE COMPARATOR

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.

Procedure: apically positioned flap with Mucograft

Interventions

Apically positioned flap PROCEDURE

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.

Apically positioned flap

Free Gingival Graft PROCEDURE

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

Free Gingival Graft

apically positioned flap with Mucograft PROCEDURE

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.

Apically positioned flap with Mucograft

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for 2nd stage implant surgery at the periodontology clinic of TUSDM.
• Inadequate keratinized tissue (0.1mm- \<2mm of buccal keratinized mucosa prior to the time of 2nd stage surgery) at the implant site. \[4\]
• Adequate depth of buccal vestibule (\>7 mm from the crest of ridge, measured at the center of surgical area) to accommodate gain of keratinized mucosa width.

You may not qualify if:

• Lack of keratinized mucosa on the area of implant.
• Autoimmune conditions which may interfere with soft tissue healing in oral cavity, e.g., pemphigus vulgaris, phemphigoid
• Infectious disease (self-reported - HIV, tuberculosis or hepatitis)
• Pregnant patients, as part of TUSDM standard of care not to treat for non-emergency surgical procedures
• Uncontrolled diabetes, defined as HbA1c \>=7, values measured within six months
• Previous gingival grafting procedure on the area.
• Smoking (\>3 cigarettes per day)
• Subjects with known hypersensitivity to study materials or objection to use of porcine material (religious or cultural reasons)
• Known allergy to codeine

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Mucograft

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2016
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

US (1)