Pinhole Surgical Technique With And Without Use Of Buttons For Treatment Of Multiple Gingival Recessions: RCT
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 17, 2015
December 1, 2015
2.2 years
December 15, 2015
December 15, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Mean Root Coverage
6 months
Complete Root Coverage
6 months
Root Coverage Esthetic Score
6 months
Recession Depth Reduction
6 months
Secondary Outcomes (7)
Gingival Recession Width Reduction
6 months
Probing Depth (PD)
6 months
Clinical Attachment Level (CAL)
6 months
Keratinized Tissue Width (KTW)
6 months
Bleeding Index (BI)
6 months
- +2 more secondary outcomes
Study Arms (2)
Pinhole surgery with orthodontic buttons
ACTIVE COMPARATORPinhole 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 buttons
ACTIVE COMPARATORPinhole 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krishnadevaraya College of Dental Sciences and Hospital
Bangalore, Karnataka, 562157, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Joann P George, MDS
Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagara, Hunsamaranahalli, International Airport Road, Bangalore 562157
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 17, 2015
Study Start
November 1, 2013
Primary Completion
January 1, 2016
Study Completion
March 1, 2016
Last Updated
December 17, 2015
Record last verified: 2015-12