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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02632968
• Other study ID #: 02_D012_44452
• Status: Recruiting
• Phase: Phase 4
• First received: December 15, 2015
• Last updated: December 15, 2015
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: Dr. Joann P George, MDS
• Phone: 9448541637
• Email: drjoannpaulinegeorge[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Multiple (atleast two or three) Millers class I and II or combined class I and II recession defects18 affecting adjacent teeth of the maxillary arch.

• Patients with thick gingival biotypes >0.8mm.

• Presence of adequate keratinized tissue apical to recession > 1mm.

• Age group 25-55 years.

• Patients with history of compliance to oral hygiene instructions and a full mouth plaque score of <10%.

• Patients willing to participate in the study.

• American Society of Anaesthesiologists Physical Status I or II.

• No contra-indications for periodontal surgery.

• Non-Smokers.

• Patients with esthetic concerns.

Exclusion Criteria:

• Recession defects associated with caries/demineralization, restorations, and deep abrasions (step >2mm).

• No occlusal interferences.

• Teeth with evidence of pulpal pathology.

• Patients who have undergone any previous periodontal surgical procedures at the involved sites.

• Pregnant and lactating women.

• Patients on medications known to interfere with periodontal tissue health or healing.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Pinhole surgery with and without buttons

Locations

Country	Name	City	State
India	Krishnadevaraya College of Dental Sciences and Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Mean Root Coverage		6 months
Primary	Complete Root Coverage		6 months
Primary	Root Coverage Esthetic Score		6 months
Primary	Recession Depth Reduction		6 months
Secondary	Gingival Recession Width Reduction		6 months
Secondary	Probing Depth (PD)		6 months
Secondary	Clinical Attachment Level (CAL)		6 months
Secondary	Keratinized Tissue Width (KTW)		6 months
Secondary	Bleeding Index (BI)		6 months
Secondary	Gingival Index (GI)		6 month
Secondary	Plaque Index		6 months