Gingival Augmentation Around Implants During Maintenance
NCT ID: NCT02904551
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-02-29
2016-06-30
Brief Summary
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Detailed Description
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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.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental
Free gingival grafts
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.
Control
Oral prophylaxis
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. implant restoration is single unsplinted unit, and has been in function for at least 6 months with an opposing dentition.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Se-Lim Oh
Assistant Professor
Principal Investigators
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Se-Lim Oh, DMD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Maryland School of Dentistry
Locations
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Advanced General Dentistry at UMB DS
Baltimore, Maryland, United States
Countries
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Other Identifiers
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HR-00051371
Identifier Type: -
Identifier Source: org_study_id