Gingival Augmentation Around Implants During Maintenance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Free Gingival Grafts for Implants Exhibiting Lack of Keratinized Gingiva: A Prospective Controlled Randomized Clinical Study

Conditions
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Failure of Dental Implant Due to Lack of Attached Gingiva

Intervention / Treatment
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* Procedure: Free gingival graft
* Procedure: Oral prophylaxis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Free gingival grafts | Procedure: Free gingival graft<br>* 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.<br>* Other names: Experimental;|
| Active Comparator: Control<br>Oral prophylaxis | Procedure: Oral prophylaxis<br>* 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.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months |  | 6, 12, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective study, free gingival graft, keratinized gingiva, dental implant