Clinical Trial: Non-Pedicled Buccal Fat Pad Graft in the Treatment of Gingival Recessions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Innovation Technique With Non-pedicled Buccal Fat Pad Graft in the Treatment of Gingival Recessions: a Randomized Controlled Clinical Trial

Brief Summary:

Background: This randomized controlled clinical study of split-mouth aimed to compare non-pedicled buccal fat pad graft (BFPG) with subepithelial connective tissue graft (SCTG) in the treatment of Miller Class I or II gingival recessions.

Methods: Twelve patients with Miller Class I or II (≥ 2 mm) bilateral recessions in maxillary premolars or canines were selected. The recessions were randomly assigned to receive SCTG (Control Group) or BFPG (Test Group). The clinical parameters of Gingival Index (GI), Plaque Index (PI), Probing Depth (PD), Gingival Recession (GR), Clinical Attachment Level (CAL), Width of Keratinized Tissue (WKT), Thickness of Keratinized Tissue (TKT) and Gingival Margin to the Acrylic Guide (GM-AG) were evaluated at baseline, and in the postoperative periods of 1, 3, and 6 months. The percentage of root coverage was also evaluated. Data were submitted to repeated measures ANOVA, Bonferroni method and t-test (p<0.05).

Detailed Summary:

MATERIALS AND METHODS

Study population This paper aims to report a randomized controlled clinical study of split-mouth. 12 patients were selected, 8 women and 4 men, aged between 21 and 65 (mean age 41 ± 11.9 years). They were informed about the risks and benefits of this clinical investigation as well as associated procedures, and signed a free and informed consent form. This study was approved by the Ethics and Research Committee of Positivo University (083/2010).

The inclusion criteria for the selection of patients were: 1) patients with Miller Class I or II gingival recessions located bilaterally in the vestibular surface of upper premolars or canines ≥ to 2 mm; 2) patients who had recessions with some differences between the right and the left sides ≤ to 3 mm; 3) non-smokers; 4) non-pregnant patients; 5) systemically healthy patients; 6) periodontally healthy patients with no contraindications for periodontal surgery; 7) patients who did not take any kind of medicine that could interfere with the health of gingival and periodontal tissue; 8) teeth with probing depth (PD) <3 mm and without bleeding on probing (BOP); 9) teeth with no caries or restorations in the cervical region; and 10) region that had not been undergone any periodontal surgery before.

Initial therapy The patients underwent a basic periodontal treatment including scaling, root planing, tooth polishing and oral hygiene instructions as required. Additionally, all patients were included in a pre-treatment program in order to eliminate possible etiological factors related to gingival recession. Patients were instructed to perform a non-traumatic brushing technique by using a toothbrush with soft bristles. The surgical procedure was performed only in patients who had adequate plaque contr
Sponsor: Universidade Positivo

Current Primary Outcome:

• Change in Probing Depth (PD) [ Time Frame: Baseline, 1, 3, and 6 months respectively ]
  measure from the gingival margin (GM) up to the bottom of the gingival sulcus
• Change in Gingival Recession (GR) [ Time Frame: Baseline, 1, 3, and 6 months respectively ]
  measure from the Cemento-Enamel Junction (CEJ) up to the GM
• Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline, 1, 3, and 6 months respectively ]
  measure from the CEJ up to the bottom of the gingival sulcus
• Change in Width of Keratinized Tissue (WKT) [ Time Frame: Baseline, 1, 3, and 6 months respectively ]
  measure from the Mucogingival Junction (MGJ) up to the GM
• Change in Thickness of Keratinized Tissue (TKT) [ Time Frame: Baseline, 1, 3, and 6 months respectively ]
  measure performed with the aid of a North Carolina periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA) perpendicularly placed along the tooth axis in the most central portion of the keratinized tissue, between the GM and the MGJ

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidade Positivo

Dates:
Date Received: March 6, 2015
Date Started: November 2010
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015