Gingival Augmentation Around Implants During Maintenance

NCT02904551 | Completed

• 1 other identifier: HR-00051371
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline, were assessed at 18 months.

Conditions

Failure of Dental Implant Due to Lack of Attached Gingiva

Keywords

prospective study; free gingival graft; keratinized gingiva; dental implant

Outcome Measures

Primary Outcomes (1)

• Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months

  6, 12, 18 months

Study Arms (2)

Experimental

EXPERIMENTAL

Free gingival grafts

Procedure: Free gingival graft

Control

ACTIVE COMPARATOR

Oral prophylaxis

Procedure: Oral prophylaxis

Interventions

Free gingival graft PROCEDURE

After infiltration anesthesia, a recipient bed was prepared with a horizontal split-thickness incision made with a 15 stainless steel blade at the mucogingival junction (MGJ) on the facial side of the selected implants. An intermediate thickness (0.75 mm) graft was taken from the palate. The graft was sutured with 6-0 polypropylene suture at the recipient site. Co-Pak® was applied on the recipient site. Analgesics (over-the-counter Tylenol or Ibuprofen) were prescribed for 5-7 days. PeridexTM (3M, St. Paul, MN) was prescribed for 7-10 days. No antibiotics were prescribed in relation to the surgery.

Also known as: Experimental

Experimental

Oral prophylaxis PROCEDURE

Oral prophylaxis is a regular dental cleaning. Titanium periodontal curette and superfloss were used on implant sites. Stainless steel periodontal curettes and a piezo scaler were used for natural teeth.

Also known as: Control

Control

Eligibility Criteria

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

You may qualify if:

• less than 2 mm KG present on the facial side of implant
• implant restoration is single unsplinted unit, and has been in function for at least 6 months with an opposing dentition.

You may not qualify if:

• uncontrolled hypertension
• diabetes mellitus (DM),
• subjects with a history of a long-term (\>6 months) use of corticosteroid
• subjects currently taking bisphosphonates, or with a history of taking bisphosphonates regardless of route of administration
• subjects on medications that cause gingival hyperplasia
• smokers
• pregnant women.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Advanced General Dentistry at UMB DS

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Se-Lim Oh, DMD, MS

  University of Maryland School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 19, 2016
• Study Start: February 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 11, 2024

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)