Gingival Augmentation Around Implants During Maintenance

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Failure of Dental Implant Due to Lack of Attached Gingiva

Treatments: Procedure: Free gingival graft; Procedure: Oral prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT02904551

HR-00051371

Details and patient eligibility

About

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.

Full description

The purpose of this study was to evaluate clinical and radiographic outcomes following free gingival grafts (FGGs) around implants with limited keratinized gingiva (KG) compared to oral prophylaxis without gingival augmentation.

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.

There was a significant gain in KG with a reduction in GR in the FGG group compared to controls at 6, 12, and 18 months. The mean PI and GI were significantly lower for the FGG group at 12 and 18 months.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental

Experimental group

Description:

Free gingival grafts

Treatment:

Procedure: Free gingival graft

Control

Active Comparator group

Description:

Oral prophylaxis

Treatment:

Procedure: Oral prophylaxis