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

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ClinicalTrials.gov Identifier: NCT02632968
Recruitment Status : Unknown
Verified December 2015 by Krishnadevaraya College of Dental Sciences & Hospital.
Recruitment status was:  Recruiting
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Krishnadevaraya College of Dental Sciences & Hospital

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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: Pinhole surgery with and without buttons Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : November 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Pinhole surgery with orthodontic buttons
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.
Procedure: Pinhole surgery with and without buttons
Active Comparator: Pinhole surgery without buttons
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.
Procedure: Pinhole surgery with and without buttons



Primary Outcome Measures :
  1. Percentage of Mean Root Coverage [ Time Frame: 6 months ]
  2. Complete Root Coverage [ Time Frame: 6 months ]
  3. Root Coverage Esthetic Score [ Time Frame: 6 months ]
  4. Recession Depth Reduction [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Gingival Recession Width Reduction [ Time Frame: 6 months ]
  2. Probing Depth (PD) [ Time Frame: 6 months ]
  3. Clinical Attachment Level (CAL) [ Time Frame: 6 months ]
  4. Keratinized Tissue Width (KTW) [ Time Frame: 6 months ]
  5. Bleeding Index (BI) [ Time Frame: 6 months ]
  6. Gingival Index (GI) [ Time Frame: 6 month ]
  7. Plaque Index [ Time Frame: 6 months ]


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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632968


Contacts
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Contact: Dr. Joann P George, MDS 9448541637 drjoannpaulinegeorge@gmail.com
Contact: Dr. Divya Khanna, MDS (BDS) 9910986765 drdivyakhanna31@gmail.com

Locations
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India
Krishnadevaraya College of Dental Sciences and Hospital Recruiting
Bangalore, Karnataka, India, 562157
Contact: Joann P George, MDS    9448541637    drjoannpaulinegeorge@gmail.com   
Contact: Divya Khanna, MDS (BDS)    9910986765    drdivyakhanna31@gmail.com   
Sponsors and Collaborators
Krishnadevaraya College of Dental Sciences & Hospital
Investigators
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Study Director: Dr. Joann P George, MDS Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagara, Hunsamaranahalli, International Airport Road, Bangalore 562157
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Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT02632968    
Other Study ID Numbers: 02_D012_44452
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy