An interventional study of Free gingival graft and Oral prophylaxis in Failure of Dental Implant Due to Lack of Attached Gingiva, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
Free gingival grafts
Procedure: Free gingival graft
Oral prophylaxis
Procedure: Oral prophylaxis
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
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
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months
Time frame: 6, 12, 18 months
Plan to share: No — IPD will not be shared. The results will be published.
No publications or documents are linked to this record.
The record gives a start of Feb 2012, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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