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Completed

NCT Number: NCT02904551

Gingival Augmentation Around Implants During Maintenance

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.

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Key information

Conditions

Failure of Dental Implant Due to Lack of Attached Gingiva

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced General Dentistry at UMB DS

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free gingival graft

Procedure

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.

Other names: Experimental

Oral prophylaxis

Procedure

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 names: Control

Primary outcomes

  1. Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months

    Time frame: 6, 12, 18 months

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2016
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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