Clinical Trial: Pinhole Surgical Technique With And Without Use Of Buttons For Treatment Of Multiple Gingival Recessions: RCT

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial

Brief Summary: Pinhole surgical technique is a novel minimally invasive, predictable, efficient, time and cost-effective technique for treatment of multiple gingival recession. This procedure involves no releasing incision, suturing or sharp dissections. It has been shown that the greater post-operative displacement of gingival margin may cause greater root coverage. Based on this hypothesis, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of pinhole surgical technique with and without the use of orthodontic buttons and sutures in the treatment of multiple gingival recessions.

Detailed Summary:

To achieve multiple adjacent recession coverage and an optimal integration of the associated tissues is even more challenging and a complex endeavour in comparison to isolated gingival recessions. Treatment protocol and outcome with different surgical procedures depends on a variety of factors like recession, defect size, presence or absence of keratinized tissue adjacent to the defect, width and height of inter-dental soft tissue, depth of vestibule, presence of frenum, post-operative stabilization and final position of advanced gingival margin. The final position of the GM plays a critical role in achieving CRC. Based on this hypothesis, a split mouth clinical trial was planned to compare the clinical outcome of pinhole surgical technique with and without the use of orthodontic buttons and sutures in the treatment of multiple gingival recessions.

METHOD The aim of this split-mouth randomized controlled clinical trial was to clinically compare and evaluate the effectiveness and predictability of Pinhole surgical technique alone and its modification with orthodontic buttons and sutures in 80 sites for the treatment of multiple gingival recessions and to assess the influence of these surgical procedures on the gingival and periodontal health, in the maxillary arch for six months post surgically. Gingival recession depth (GRD), Gingival margin location post-surgery, Gingival recession width (GRW), Root coverage esthetic score (RES), Complete root coverage (CRC), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment.


Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Current Primary Outcome:

  • Percentage of Mean Root Coverage [ Time Frame: 6 months ]
  • Complete Root Coverage [ Time Frame: 6 months ]
  • Root Coverage Esthetic Score [ Time Frame: 6 months ]
  • Recession Depth Reduction [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gingival Recession Width Reduction [ Time Frame: 6 months ]
  • Probing Depth (PD) [ Time Frame: 6 months ]
  • Clinical Attachment Level (CAL) [ Time Frame: 6 months ]
  • Keratinized Tissue Width (KTW) [ Time Frame: 6 months ]
  • Bleeding Index (BI) [ Time Frame: 6 months ]
  • Gingival Index (GI) [ Time Frame: 6 month ]
  • Plaque Index [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Krishnadevaraya College of Dental Sciences & Hospital

Dates:
Date Received: December 15, 2015
Date Started: November 2013
Date Completion: March 2016
Last Updated: December 15, 2015
Last Verified: December 2015