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CTRI Number  CTRI/2020/12/029817 [Registered on: 15/12/2020] Trial Registered Prospectively
Last Modified On: 14/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pin hole Surgical technique and Semilunar Coronally Repositioned flap for treatment of Gingival Recession 
Scientific Title of Study   comparative evaluation of pin hole surgical technique and semilunar coronally repositioned flap for treatment of gingival recession 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kunche lavanya 
Designation  MDS 
Affiliation  Institute of Dental Sciences 
Address  Department of Periodontology and Implantology, Institute of Dental Sciences,Pilibith bypass road, Bareilly, Uttarpradesh-243006 India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8466904776  
Fax    
Email  drklavanyaperio@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manvi Agarwal 
Designation  professor 
Affiliation  Institute of Dental Sciences 
Address  Department of Periodontology and Implantology, Institute of Dental Sciences,Pilibith bypass road, Bareilly, Uttarpradesh-243006 India
Department of Periodontology and Implantology, Institute of Dental Sciences,Pilibith bypass road, Bareilly, Uttarpradesh 243006
Bareilly
UTTAR PRADESH
243006
India 
Phone  9457540800  
Fax    
Email  agarwalmanvi25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  kunche lavanya 
Designation  MDS 
Affiliation  Institute of Dental Sciences 
Address  Department of Periodontology and Implantology, Institute of Dental Sciences,Pilibith bypass road, Bareilly, Uttarpradesh-243006 India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8466904776  
Fax    
Email  drklavanyaperio@gmail.com  
 
Source of Monetary or Material Support  
rohilkhand medical college and hospital Institute of dental sciences near pilibhit bypass 243006 
 
Primary Sponsor  
Name  Dr Lavanya Kunche 
Address  institute of dental sciences rohilkhand medical college and hospital pilibhit bypass bareilly uttar pradesh 243006 
Type of Sponsor  Other [private dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
lavanya kunche  institute of dental sciences  rohilkhand medical college and hospital institute of dental sciences department of periodontology and implantology pilibhit bypass
Bareilly
UTTAR PRADESH 
8466904776

drklavanyaperio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute of dental sciences bareilly  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M272||Inflammatory conditions of jaws,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  pinhole surgical techique  involves a round incision of 2mm above the gingival margin. Used s a root coverage technique. 
Intervention  semilunar coronally repositioned flap technique  a semilunar incison is given 2mm away from gingival margin not extending deep into the interdental gingiva. Used s a root coverage technique with better results. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Presence of maxillary single or multiple buccal recessions in the anterior region classified as class I
2. Absence of restoration or crowns and non-identifiable cemento-enamel junction(CEJ)
3. Plaque and bleeding score should be <25% 
 
ExclusionCriteria 
Details  1. Systemically compromised individuals with diabetes mellitus, history of malignancies, bleeding disorders or any other chronic inflammatory disease eg-rheumatoid arthritis.
2. Pregnant women and lactating mothers.
3. Patients on antibiotic therapy.
4. Patients who underwent any surgical periodontal therapy in the last six months.
5.Smokers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the clinical outcome of Pin hole surgical technique and Semilunar coronally advanced flap in maxillary anterior region of Miller’s class I gingival recession.  baseline, 3 months and 6 months post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the recession coverage in pin hole surgical technique.

To assess the recession coverage in semilunar coronally repositioned flap technique.

To compare the effectiveness of recession coverage by both the surgical techniques and find out if any technique is superior to other.
 
baseline, 3 months and 6 months post-operatively. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   23/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Intervention / Procedure:

Procedure performed by a single operator. The patients’ will be explained about the surgical procedures (Appendix I) and the possible outcomes in their vernacular language as well as written informed consent (Appendix II) shall be obtained. The demographic data of all the subjects will be recorded on the customized case history proforma (Appendix III).

The study will be conducted in patients with single or multiple Miller’s class I gingival recession defects. Clinical parameters like recession height (RH), the distance from the CEJ to gingival margin, recession width (RW), meiso-distal diameter at the CEJ, probing sulcus depth (PD), clinical attachment level (CAL), the sum of recession depth and probing depth, and width of keratinized tissue (KTW) i.e., distance from marginal gingiva to the mucogingival junction will be assessed.

In case of semilunar coronally repositioned flap, a semilunar incision, will be given following the curvature of the free gingival margin. The incision will curve apically far enough mid facially to ensure that the apical part of the flap rests on bone after it is brought down to cover the exposed root.

Incision will end into the papillae on each end of the tooth, but not all the way to the tip of the papillae, at least 2 mm will be left on either side of the flap. Using a 15c blade, split thickness dissection will be made from the initial incision line coronally, connected with an intrasulcular incision made mid facially.

Mid facial tissue will be then coronally positioned to the CEJ or to the height of adjacent papillae in case of interproximal recession. Tissue will be held in place against the tooth with moist gauze for 5 min.

In case of pin hole surgical technique, a minimal horizontal incision of 2 to 3mm will be made in the alveolar mucosa near the base of the vestibule apical to recipient site. Specially designed instruments [Transmucosal periosteal elevators right and left] are inserted through the entry of incision to elevate full thickness flap and will be guided by visualization of the shape and movement of the instruments through the mucosa and gingival tissue. This interproximal extension of the flap will result in a freely movable flap, which will be then positioned coronally to extend beyond the CEJ. For stabilization of flap, sutures will be used.

 
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