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

NCT02393053 | Completed

• 1 other identifier: PositivoU
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gingival Recession

Keywords

Gingival Recession; Case-Control Studies; Adipose Tissue

Outcome Measures

Primary Outcomes (5)

• Change in Probing Depth (PD)

  measure from the gingival margin (GM) up to the bottom of the gingival sulcus

  Baseline, 1, 3, and 6 months respectively

• Change in Gingival Recession (GR)

  measure from the Cemento-Enamel Junction (CEJ) up to the GM

  Baseline, 1, 3, and 6 months respectively

• Change in Clinical Attachment Level (CAL)

  measure from the CEJ up to the bottom of the gingival sulcus

  Baseline, 1, 3, and 6 months respectively

• Change in Width of Keratinized Tissue (WKT)

  measure from the Mucogingival Junction (MGJ) up to the GM

  Baseline, 1, 3, and 6 months respectively

• Change in Thickness of Keratinized Tissue (TKT)

  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

  Baseline, 1, 3, and 6 months respectively

Study Arms (2)

subepithelial connective tissue graft

SHAM COMPARATOR

Surgery: Treatment with subepithelial connective tissue graft for gingival recession

Procedure: Treatment with subepithelial connective tissue graft (SCTG)

non-pedicled buccal fat pad graft

EXPERIMENTAL

Surgery: Treatment with non-pedicled buccal fat pad graft for gingival recession

Procedure: Treatment with non-pedicled buccal fat pad graft (BFPG)

Interventions

Treatment with subepithelial connective tissue graft (SCTG) PROCEDURE

Miller Class I or II gingival recessions were treated with subepithelial connective tissue graft (SCTG)

subepithelial connective tissue graft

Treatment with non-pedicled buccal fat pad graft (BFPG) PROCEDURE

Miller Class I or II gingival recessions were treated with non-pedicled buccal fat pad graft (BFPG)

non-pedicled buccal fat pad graft

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Miller Class I or II gingival recessions located bilaterally in the vestibular surface of upper premolars or canines ≥ to 2 mm
• Patients who had recessions with some differences between the right and the left sides ≤ to 3 mm
• Non-smokers
• Non-pregnant patients
• Systemically healthy patients
• Periodontally healthy patients with no contraindications for periodontal surgery
• Patients who did not take any kind of medicine that could interfere with the health of gingival and periodontal tissue
• Teeth with probing depth (PD) \<3 mm and without bleeding on probing (BOP)
• Teeth with no caries or restorations in the cervical region
• Region that had not been undergone any periodontal surgery before

Sponsors & Collaborators

• Universidade Positivo: lead

Related Publications (6)

• Kassab MM, Badawi H, Dentino AR. Treatment of gingival recession. Dent Clin North Am. 2010 Jan;54(1):129-40. doi: 10.1016/j.cden.2009.08.009.

  PMID: 20103476 BACKGROUND

• Zucchelli G, Testori T, De Sanctis M. Clinical and anatomical factors limiting treatment outcomes of gingival recession: a new method to predetermine the line of root coverage. J Periodontol. 2006 Apr;77(4):714-21. doi: 10.1902/jop.2006.050038.

  PMID: 16584355 BACKGROUND

• Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.

  PMID: 24641000 BACKGROUND

• de Sanctis M, Baldini N, Goracci C, Zucchelli G. Coronally advanced flap associated with a connective tissue graft for the treatment of multiple recession defects in mandibular posterior teeth. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):623-30.

  PMID: 22140664 BACKGROUND

• Bittencourt S, Ribeiro Edel P, Sallum EA, Sallum AW, Nociti FH, Casati MZ. Semilunar coronally positioned flap or subepithelial connective tissue graft for the treatment of gingival recession: a 30-month follow-up study. J Periodontol. 2009 Jul;80(7):1076-82. doi: 10.1902/jop.2009.080498.

  PMID: 19563287 BACKGROUND

• El Haddad SA, Abd El Razzak MY, El Shall M. Use of pedicled buccal fat pad in root coverage of severe gingival recession defect. J Periodontol. 2008 Jul;79(7):1271-9. doi: 10.1902/jop.2008.070176.

  PMID: 18597611 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Flares Baratto Filho, PhD

  Universidade Positivo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 19, 2015
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2012
• Last Updated: March 19, 2015

Record last verified: 2015-03