| CTRI Number |
CTRI/2025/10/096314 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares how well different floss tie methods work to keep the tooth dry and clean during the cementation of dental restorations and to see which method gives the best outcome clinically. |
|
Scientific Title of Study
|
Comparative clinical evaluation of efficacy of different floss tie isolation technique for adhesive cementation of dental restorations- An In Vivo Study. |
| 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 Ruchi Kumar Purbey |
| Designation |
PG student |
| Affiliation |
KM Shah dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics
KM Shah dental college and hospital Sumandeep Vidyapeeth university waghodia vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
09755975516 |
| Fax |
|
| Email |
ruchikumar2507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Head of the department |
| Affiliation |
KM Shah dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics
KM Shah dental college and hospital Sumandeep Vidyapeeth university waghodia vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Head of the department |
| Affiliation |
KM Shah dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics
KM Shah dental college and hospital Sumandeep Vidyapeeth university waghodia vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah Dental College and Hospital
Sumandeep vidhyapeeth University , Waghodia, Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Ruchi Kumar Purbey |
| Address |
KM Shah dental college and hospital, Sumandeep Vidhyapeeth University, Waghodia, Vadodara, Gujrat , India Pincode:391760 |
| 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 Ruchi Kumar Purbey |
KM Shah dental college and hospital |
Room no. 8 Department of conservative dentistry and endodontics
KM Shah dental college and hospital Sumandeep Vidyapeeth university waghodia vadodara
Vadodara
GUJARAT |
09755975516
ruchikumar2507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep VIdhyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cocofloss |
To evaluate and compare the clinical efficacy and post operative pain of Cocofloss as floss tie isolation technique with conventional and PTFE floss for adhesive cementation of dental restorations . |
| Comparator Agent |
Conventional floss |
To evaluate and compare the clinical efficacy and post operative pain of Conventional floss as floss tie isolation technique with PTFE and cocofloss for adhesive cementation of dental restorations . |
| Intervention |
PTFE floss |
To evaluate and compare the clinical efficacy and post operative pain of PTFE as floss tie isolation technique with conventional and cocofloss for adhesive cementation of dental restorations . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age group of 18 to 65 years is included in study.
2.Tooth preparation with equi-gingival finish line.
3.A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with poor oral hygiene and gingival/periodontal diseases will be excluded from the study.
2.Patients with latex allergy will be excluded.
3.Tooth with subgingival caries, cracks will be excluded.
4.Medically compromised patients will be excluded from the study.
5.Badly mutilated teeth which are difficult for isolation will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the clinical efficacy of conventional, PTFE and cocofloss as isolation techniques for adhesive cementation of dental restorations using self-designed criteria. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess post operative pain of conventional, PTFE and cocofloss as isolation techniques for adhesive cementation of dental restorations using Verbal Rating scale |
baseline, 6 hours and 12 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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) |
Open to Recruitment |
|
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
|
To evaluate and compare the clinical efficacy of conventional, PTFE and Cocofloss as isolation techniques for adhesive cementation of dental restorations using self-designed criteria. Post operative pain assessment will be done using Verbal Rating scale at baseline, 6hrs and 12 hrs interval. Results of the study will help us to know which material clinically performs better for the isolation during cementation of dental restorations. |