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CTRI Number  CTRI/2025/03/082289 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   To compare the amount of gum displacement produced by two different retraction cord materials  
Scientific Title of Study   Comparative evaluation of the gingival displacement by conventional and customized polytetrafluoroethylene (PTFE) retraction cord -A split mouth clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surabhi S 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8310773947  
Fax    
Email  ssurabhi2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deviprasad Nooji 
Designation  Professor 
Affiliation  KVG Dental College and Hospital 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448688673  
Fax    
Email  devinooji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deviprasad Nooji 
Designation  Professor 
Affiliation  KVG Dental College and Hospital 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448688673  
Fax    
Email  devinooji@gmail.com  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 
 
Primary Sponsor  
Name  Dr Surabhi S 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 
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 Surabhi S  KVG Dental College and Hospital  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 
8310773947

ssurabhi2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amount of gingival displacement produced by conventional retraction cord size 000  conventional retraction cord of size 000 is used. two sets of impression will be made with and without retraction cord to check for the amount of displacement produced which will be later compared with displacement produced by customized polytetrafluorethylene (PTFE) retraction cord. Displacement checked during baseline and after 2 weeks. 
Intervention  Amount of gingival displacement produced by customized polytetrafluorethylene (PTFE) retraction cord  customized polytetrafluorethylene retraction cord made by rolling it between two glass slab such that the diameter is same as the conventional retraction cord of size 000. later two impressions will be made with and without retraction cord to check for the amount of displacement produced by the customized retraction cord .Displacement checked during baseline and after 2 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients with healthy mandibular 2nd premolar with both sides teeth should have nearly similar size and anatomy with probing depth less than 3mm. 
 
ExclusionCriteria 
Details  1.Bleeding on probing.
2.High plaque index.
3.Gingival recession.
4.Developmental anomalies or anatomical variations.
5.Pre-existing systemic conditions.
6.Thin gingival biotype
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the amount of gingival displacement produced by conventional and customized polytetrafluorethylene (PTFE) retraction cord.  Baseline, 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the amount of gingival displacement produced by conventional retraction cord size 000.  Baseline, 2 weeks 
2.To evaluate the amount of gingival displacement produced by customized polytetrafluorethylene (PTFE) retraction cord.  Baseline, 2 weeks 
 
Target Sample Size   Total Sample Size="13"
Sample Size from India="13" 
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 
Date of First Enrollment (India)   05/05/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

In fixed restoration, gingival displacement plays an important role in excellent reproduction of marginal details. Gingival retraction involves deflection of gingival tissues away from the tooth to expose the cervical part or margins of prepared tooth. A sulcular width of 0.15 to 0.20 mm is needed for accurate impression. If the sulcus width is less than this value, impression material is subjected to rupture and deformation, with reduced marginal accuracy. An inappropriate gingival displacement technique can be a primary factor in defective recording of marginal details. Various methods for gingival retraction are mechanical, mechanochemical, electrosurgery, rotary gingival curettage, laser etc. Following are few acceptable criteria during gingival displacement:(1) Minimum of 0.22 mm space laterally and vertically should be present between finish line and gingiva for impression material to record without distortion. (2) for accurate trimming of recovered die additionally small amount of impression material should flow beyond prepared margins, (3) especially when elastomeric impression material, gingival fluid seepage and hemorrhage should be considered (4) protection from irreversible hard and soft tissue damages, (5) protection against dangerous systemic effects. Mechanical method of gingival retraction uses both impregnated and non-impregnated retraction cords. Common disadvantages including damage to junctional epithelium, post-retraction inflammation and gingival recession, bleeding and patient discomfort during procedure and technique sensitive. Various other techniques have been introduced to overcome all these disadvantages thereby replacing the use of retraction cord which includes retraction paste, gels, foams, lasers and surgery. While researches still conclude use of retraction cord as gold standard due to its cost-effectiveness and reliability and excellent displaceability of gingiva.Polytetrafluoroethylene (PTFE) tape, a synthetic fluoropolymer. Commercially referred as Plumber’s tape or Teflon is heat stable, nonadherent with low co-efficiency of friction inert and non-reactive to oral fluids as well as other acids used in dentistry. widely used in the field of clinical dentistry for isolation and in guided bone regeneration. Use of PTFE tape for gingival retraction is limited. Recent study has shown that conventional gingival retraction cord and PTFE cord incorporated with aluminium chloride displayed similar outcomes of ease of placement and bleeding after cord removal. This study will be focusing on a new technique to standardize the use of PTFE tape for gingival retraction in comparison with conventional retraction cord on an unprepared tooth.

 

 
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