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
|
|
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
|
|
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.
|