Gingival Augmentation Around Implants During Maintenance

Not Applicable

Completed

• Conditions: Failure of Dental Implant Due to Lack of Attached Gingiva
• Interventions: Procedure: Free gingival graft; Procedure: Oral prophylaxis

• Registration Number: NCT02904551
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-19
• Status Verified: 2019-08
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Free gingival graft	Free gingival grafts
Control	Oral prophylaxis	Oral prophylaxis

Primary Outcome Measures

Name	Time	Method
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months	6, 12, 18 months

Trial Locations

Locations (1)

Advanced General Dentistry at UMB DS; 🇺🇸 Baltimore, Maryland, United States