| CTRI Number |
CTRI/2024/09/073294 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
The study to compare two methods of gums retraction during dental procedures like using a special cord soaked in a nasal relief medicine and a silk suture coated with Teflon tape |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of conventional retraction Cord soaked in Alpha adrenomimetic Decongestant and Silk suture coated with polytetrafluroethylene tape for gingival retraction 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 Charles Patel |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
room number 5 department of conservative dentistry and
endodontics narsinhbhai patel dental college and hospital
Sankalchand Patel University S Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
7779051863 |
| Fax |
|
| Email |
charlespatel2135@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and Head |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital Sankalchand patel
university Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charles Patel |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
room number 5 department of conservative dentistry and
endodontics narsinhbhai patel dental college and hospital
Sankalchand Patel University Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
7779051863 |
| Fax |
|
| Email |
charlespatel2135@gmail.com |
|
|
Source of Monetary or Material Support
|
| 5 Department of conservative dentistry and endodontics Narsinhbhai Patel Dental
College and Hospital in Visnagar Gujarat
|
|
|
Primary Sponsor
|
| Name |
Dr Charles Patel |
| Address |
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel University
Visnagar 384315 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Charles Patel |
Narsinhbhai Patel Dental College and Hospital |
Room no 5
Department of
Conservative
Dentistry Narsinhbhai
Patel Dental College
and Hospital Visnagar
Mahesana
GUJARAT
Mahesana
GUJARAT |
7779051863
charlespatel2135@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alpha adrenomimetic Decongestant |
Silk suture coated with polytetrafluroethylene tape |
| Intervention |
Silk suture coated with polytetrafluroethylene tape |
polytetrafluroethylene tape |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Requiring full coverage restoration
Sound gingival and periodontal health of the abutment teeth
Abutment teeth of normal size and contour
Maxillary anterior tooth
Teeth with probing depth of 2-3 mm.
No signs of bleeding on probing
|
|
| ExclusionCriteria |
| Details |
Any kind of gingival pathology
Tipped, tilted or rotated teeth and developmental anomaly
Class V restorations
Periodontal surgery and crown lengthening
Patients with bleeding disorders
Smokers, tobacco users
Pregnancy
Systemic diseases like diabetes, hypertension and immunocompromised patients
History of prolonged use of steroids/immunosuppressive agents/aspirin
Allergic to tetrahydrozoline and aluminum chloride
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequate Gingival Displacement and Ease of Application |
Adequate Gingival Displacement and Ease of Application of cord causing less irritation to gingiva |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [charlespatel2135@gmail.com].
- For how long will this data be available start date provided 23-06-2025 and end date provided 23-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In the era of modern dentistry, esthetics has become an integral component of treatment. Full coverage preparations often require subgingival margins because of caries, existing restorations, esthetic demands, or the need for additional retention. Gingival displacement is defined as the deflection of the marginal gingiva away from the tooth. Gingival retraction involves the displacement of marginal soft tissues around a tooth, mainly to allow access in preparation, precise impression taking and cementation procedures. Gingival tissue management generally consists of two parts. The first is gingival margin. The second part is confined to moisture control in the sulcus. Most commonly employed material to obtain gingival displacement is gingival retraction cord. Medicated cords has adequate effect in controlling hemorrhage. Nasal and Ophthalmic decongestants are potential vasoconstrictive and haemostatic agents; as it contains sympathomimetic amines, like tetrahydrozoline and oxymetazoline and it also has minimal systemic effects when used in conjunction with retraction cords. Gingival tissue management generally consists of two parts. The first is gingival margin. The second part is confined to moisture control in the sulcus. Most commonly employed material to obtain gingival displacement is gingival retraction cord. Medicated cords has adequate effect in controlling hemorrhage. Nasal and Ophthalmic decongestants are potential vasoconstrictive and haemostatic agents; as it contains sympathomimetic amines, like tetrahydrozoline and oxymetazoline and it also has minimal systemic effects when used in conjunction with retraction cords. |