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

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Pinhole surgery with and without buttons
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Krishnadevaraya College of Dental Sciences and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pinhole surgery with orthodontic buttons

Pinhole surgery without buttons

Arm Description

Pinhole surgery with orthodontic buttons The selected participants were assigned in test and control. In the test group orthodontic buttons were cemented on the bid-buccal region of the crown with dual cure GIC. After administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions. The sling sutures 5-0 mersilk were placed to hold the tunnel in an advanced location using orthodontic buttons as anchoring units. Inter-dental sutures with 6-0 mersilk were also placed for stabilization of the advanced gingival tissue.

Pinhole surgery without orthodontic buttons The selected participants were assigned in test and control. In the control group, after administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions till the recession defects were covered. No sutures or orthodontic buttons were used in the control site.

Outcomes

Primary Outcome Measures

Percentage of Mean Root Coverage
Complete Root Coverage
Root Coverage Esthetic Score
Recession Depth Reduction

Secondary Outcome Measures

Gingival Recession Width Reduction
Probing Depth (PD)
Clinical Attachment Level (CAL)
Keratinized Tissue Width (KTW)
Bleeding Index (BI)
Gingival Index (GI)
Plaque Index

Full Information

First Posted
December 15, 2015
Last Updated
December 15, 2015
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02632968
Brief Title
Pinhole Surgical Technique With And Without Use Of Buttons For Treatment Of Multiple Gingival Recessions: RCT
Official Title
Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pinhole surgery with orthodontic buttons
Arm Type
Active Comparator
Arm Description
Pinhole surgery with orthodontic buttons The selected participants were assigned in test and control. In the test group orthodontic buttons were cemented on the bid-buccal region of the crown with dual cure GIC. After administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions. The sling sutures 5-0 mersilk were placed to hold the tunnel in an advanced location using orthodontic buttons as anchoring units. Inter-dental sutures with 6-0 mersilk were also placed for stabilization of the advanced gingival tissue.
Arm Title
Pinhole surgery without buttons
Arm Type
Active Comparator
Arm Description
Pinhole surgery without orthodontic buttons The selected participants were assigned in test and control. In the control group, after administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions till the recession defects were covered. No sutures or orthodontic buttons were used in the control site.
Intervention Type
Procedure
Intervention Name(s)
Pinhole surgery with and without buttons
Primary Outcome Measure Information:
Title
Percentage of Mean Root Coverage
Time Frame
6 months
Title
Complete Root Coverage
Time Frame
6 months
Title
Root Coverage Esthetic Score
Time Frame
6 months
Title
Recession Depth Reduction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Gingival Recession Width Reduction
Time Frame
6 months
Title
Probing Depth (PD)
Time Frame
6 months
Title
Clinical Attachment Level (CAL)
Time Frame
6 months
Title
Keratinized Tissue Width (KTW)
Time Frame
6 months
Title
Bleeding Index (BI)
Time Frame
6 months
Title
Gingival Index (GI)
Time Frame
6 month
Title
Plaque Index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Joann P George, MDS
Phone
9448541637
Email
drjoannpaulinegeorge@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Divya Khanna, MDS (BDS)
Phone
9910986765
Email
drdivyakhanna31@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Joann P George, MDS
Organizational Affiliation
Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagara, Hunsamaranahalli, International Airport Road, Bangalore 562157
Official's Role
Study Director
Facility Information:
Facility Name
Krishnadevaraya College of Dental Sciences and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joann P George, MDS
Phone
9448541637
Email
drjoannpaulinegeorge@gmail.com
First Name & Middle Initial & Last Name & Degree
Divya Khanna, MDS (BDS)
Phone
9910986765
Email
drdivyakhanna31@gmail.com

12. IPD Sharing Statement

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

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