Gingival Augmentation Around Implants During Maintenance

Failure of Dental Implant Due to Lack of Attached Gingiva Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904551
• Other study ID #: HR-00051371
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Failure of Dental Implant Due to Lack of Attached Gingiva

Intervention

Procedure:
• Free gingival graft
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.
• Oral prophylaxis
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.

Locations

Country	Name	City	State
United States	Advanced General Dentistry at UMB DS	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months		6, 12, 18 months