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CTRI Number  CTRI/2024/09/073544 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   " A study designed to compare if the Root Plastique Technique is better to be done alone or in combination with I-PRF to cover the exposed root surface with Non Carious Cervical lesions " 
Scientific Title of Study   To compare the effectiveness of Root Plastique Technique with or without I-PRF on root coverage and gingival phenotype in subjects with Non Carious Cervical lesions – A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
25/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muskan Gupta 
Designation  Post Graduate 
Affiliation  JSS Academy of Higher Education and Research 
Address  Room no 9, Department of Periodontology, JSS Dental college and hospital, Mysuru

Mysore
KARNATAKA
570015
India 
Phone  8930877425  
Fax    
Email  Aashigarg1204@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Avinash BS 
Designation  Reader 
Affiliation  JSS Academy of Higher Education and Research 
Address  Room no 9, Department of Periodontology, JSS Dental college and hospital, Mysuru

Mysore
KARNATAKA
570015
India 
Phone    
Fax    
Email  Dr.avinashbs@jssuni.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Muskan Gupta 
Designation  Post Graduate 
Affiliation  JSS Academy of Higher Education and Research 
Address  Room no 9, Department of Periodontology, JSS Dental college and hospital, Mysuru

Mysore
KARNATAKA
570015
India 
Phone  8930877425  
Fax    
Email  Aashigarg1204@gmail.com  
 
Source of Monetary or Material Support  
JSS Dental College and Hospital, Sri, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka 570015 
 
Primary Sponsor  
Name  Dr Muskan Gupta 
Address  Room No 9, Department of Periodontology, JSS Dental college and Hospital, Bannimantap, Mysuru, Karnataka 570015 
Type of Sponsor  Other [Self] 
 
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 
Dr Muskan Gupta  JSS Dental college and Hospital/ JSS Academy Of Higher Education and Research  Department Of Periodontology,Room no.9
Mysore
KARNATAKA 
8930877425

Aashigarg1204@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Dental college and hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy, presenting with non carious cervical lesions with recession 
Patients  (1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Root PLastique Technique alone  The Apical step of the NCCL will be eliminated using rotary burs. The first cutter is rugby ball-shaped with a diameter of 0.16 white ring, ultra-fine grain with a maximum grain size of 14 microns. The bur will be inserted into the sulcus under abundant irrigation, until it invades the supra-crestal tissue attachment causing bleeding within the sulcus. Eliminating the apical step will be done to flatten the NCCL in the apical portion. The coronal projection of the most external point of the apical border of NCCL will be removed, reaching with the bur to the bottom of the NCCL. In this way, the depth of NCCL will be eliminated. Subsequently, a final preparation drill with a diameter of 012 white ring, ultra fine grain with a maximum grain size of 8 microns will be used. The bone crest will be reached using the bur gently while checking the working depth with the probe. An ultra fine finishing bur will be used to ensure minimal cutting on the expense of soft tissue and maximum smoothness of the root surface. 
Intervention  Root plastique technique with I-PRF  Test group:- The Apical step of the NCCL will be eliminated using rotary burs. The first cutter is rugby ball-shaped with a diameter of 0.16 white ring, ultra-fine grain with a maximum grain size of 14 microns. The bur will be inserted into the sulcus under abundant irrigation, until it invades the supra-crestal tissue attachment. Eliminating the apical step will be done to flatten the NCCL in the apical portion. The coronal projection of the most external point of the apical border of NCCL will be removed, reaching with the bur to the bottom of the NCCL. In this way, the depth of NCCL will be eliminated. Subsequently, a final preparation drill with a diameter of 012 white ring, ultra fine grain with a maximum grain size of 8 microns will be used. The bone crest will be reached using the bur gently while checking the working depth with the probe. An ultra fine finishing bur will be used to ensure minimal cutting on the expense of soft tissue and maximum smoothness of the root surface. Preparation of I-PRF:- Skin will be cleaned with alcohol swabs and blood will be drawn with blood collector needle of 21 gauge. Blood will be collected in a 10ml test tube and will be subjected to centrifugation. After which the tubes will be carefully taken out from the centrifuge and placed in a test tube stand. An insulin syringe will be used to extract the buffy coat and I-PRF will be the injected at the sides mesial, mid-buccal, and distal.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  -Presence of gingival recession with NCCL and recession less then 2mm bilaterally .
- Only maxillary teeth will be included.
-Absence of caries and/or restorations in the area to be treated.
-Absence of mucogingival surgery or surgical treatment for periodontal disease at the same site in the previous 12 months.
-Full mouth plaque score (FMPS) less than 20 percent and full mouth bleeding score (FBS) less than 20 percent. 
 
ExclusionCriteria 
Details  -Systemic diseases, pregnancy and lactation.
-Smoking, use of tobacco in any form and recreational drug users.
-If the defect and GR is more than 2mm and without the presence of a gingival step.
-Any evidence of trauma from occlusion in the area to be treated.
-Malocclusion, Crowding.
-Patients with poor oral hygiene. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of root plastique technique in recession coverage using clinical methods.  Baseline, 2nd week, 6th week, 10th week, 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
-To compare the effectiveness of injectable Platelet Rich Fibrin as an adjunct to root plastique technique in recession coverage using clinical methods.

-To assess changes in gingival phenotype 
Baseline, 2nd week, 6th week, 10th week, 12th week 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/09/2024 
Date of Study Completion (India) 15/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The term gingival phenotype has been introduced to address the common clinical observation of great variation in the thickness and width of facial keratinized tissue. Gingival biotype is described as the thickness of the gingiva in the faciopalatal / faciolingual dimension. The term periodontal biotype introduced by Seibert and Lindhe categorised the gingiva into thick-flat and thin scalloped biotypes. Gingival thickness, keratinized tissue width, and bone morphotype are three important parameters used to categorise periodontal health. Thin gingival phenotype may contribute to periodontal tissue breakdown and recession development. Gingival recession (GR) is defined as the apical shift of the gingival margin with a consequent exposure of the root surface. Various factors responsible for the etiopathogenesis of GR include toothbrushrelated trauma, inflammation induced by plaque accumulation, orthodontic tooth movement, and lack of keratinized tissue thickness (KTT). GRs presents with wedge-shaped, concave, flattened, and irregular defects in the cervical area of the teeth known as non-carious cervical lesions (NCCLs). The presence of an NCCL leads to alterations in both crown and root surface that often develop into root concavities (or steps) of variable extensions and depths. There is relatively high frequency of non-carious cervical lesions among subjects of different age. Premolars are the most frequently affected teeth, therefore addressing this becomes very crucial for the clinician which if left untreated may lead to periodontitis which induces the destruction of tooth supporting tissues. There are various treatment modalities for recession coverage one of it being Platelet-rich fibrin (PRF). PRF is developed by centrifugation of blood obtained in glass tubes without anticoagulants and activators. Injectable platelet-rich fibrin (i-PRF) is produced by changing the type of the tube, centrifugation time and speed. I-PRF is prepared according to low-speed centrifugation concept which provides a significant advantage for the regeneration process, as it is rich in platelets, leucocytes and growth factors thereby increasing vascularization.The other one is a minimally invasive procedure Root plastique technique which is simple and time efficient, involves the invasion of supra-crestal tissue attachment, the stimulation of bleeding. This is performed to eliminate any obstacle to the ascent of the gingival tissue and, at the same time, to create the space needed for the thickening of the soft tissues, a space that was initially filled only by the blood clot. This provides a concave space for the formation and stability of a blood clot that will eventually lead to increased tissue thickness and keratinized tissue width.Considering these two treatment modalities, the present study aims at comparing the effectiveness of root plastique technique versus injectable PRF as an adjunct to root plastique technique in subjects with NCCLs and recession.

 
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