| CTRI Number |
CTRI/2025/06/089599 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Gentle Gum Retraction Around Implants: Comparing Two Modern Cordless Techniques |
|
Scientific Title of Study
|
Comparative evaluation of gingival displacement produced by two different cordless retraction systems around dental implant abutments – an experimental 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 |
Saloni Rustagi |
| Designation |
PG student |
| Affiliation |
Government Dental College and hospital, Nagpur |
| Address |
Departemnt no. 13, Government Dental College and hospital , Hanuman nagar, Medical chowk, Nagpur.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
09663058612 |
| Fax |
|
| Email |
salonirustagi89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sattyam Wankhade |
| Designation |
Associate professor |
| Affiliation |
Government Dental College and hospital, Nagpur |
| Address |
Departemnt no. 13, Government Dental College and hospital , Hanuman nagar, Medical chowk, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7972759022 |
| Fax |
|
| Email |
drsvw@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Saloni Rustagi |
| Designation |
PG student |
| Affiliation |
Government Dental College and hospital, Nagpur |
| Address |
Departemnt no. 13, Government Dental College and hospital , Hanuman nagar, Medical chowk, Nagpur.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
09663058612 |
| Fax |
|
| Email |
salonirustagi89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Department no 13, Hanuman Nagar, near Medical chowk , Nagpur, Maharashtra, India.
Pin: 440003 |
|
|
Primary Sponsor
|
| Name |
Saloni Rustagi |
| Address |
Department no. 13,Departement of Prosthodontics, Crown and Bridge, Government Dental College and hospital, Hanuman Nagar, Nagpur, Maharashtra, India .
Pin: 440003 |
| 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 |
| Saloni Rustagi |
Government Dental College and Hospital |
Department no 13, Government Dental College and Hospital, near medical chowk
Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA |
09663058612
salonirustagi89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, Nagpur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Humans who require implant placement in cases of missing teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baseline |
Without using and retraction material |
| Intervention |
Magic foam and 3M ESPE |
Magic Foam Cord is chemical gingival retraction cord of polyvinyl siloxane intended to produce mechanical retraction due to its own effect on foaming intraoral setting. After its application, the material is washed after 4 minutes according to manufacturers instructions.3M ESPE Paste is chemical gingival retraction paste made of kaolin and aluminum chloride, yielding hemostasis, vasoconstriction, and sulcular expansion due to positive pressure. It is applied for the time duration suggested by the manufacturer that is 3 minutes and washed immediately. The time gap between both interventions will be fourteen days. Both materials will be used once for every patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants were rigorously selected using defined inclusion and exclusion criteria to ensure comparable baseline oral health and minimize confounding factors. Healthy individuals aged 18–40 years requiring cement-retained implant prostheses in the posterior mandible or maxilla were included. Eligibility required ideal oral hygiene, indicated by no bleeding on probing, and the presence of adjacent natural teeth for digital scan referencing. Only non-smokers with no history of tobacco use were considered. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria involved patients with submerged implants or those unsuitable for abutment-level impressions. Individuals with periodontal disease—such as deep pockets, inflammation, or mobility—were excluded to avoid interference with soft tissue evaluation. Those with a thin gingival biotype were also excluded due to higher risk of sulcular trauma. Patients with systemic conditions affecting healing or soft tissue behavior, those unwilling or unable to provide informed consent, or who failed to comply with follow-up protocols were excluded according to study withdrawal guidelines. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of this study is to assess and compare the gingival displacement effectiveness of Magic Foam Cord and 3M™ ESPE™ retraction paste around dental implant abutments. |
Immediately after application of both intervention and after one week. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
25/07/2025 |
| 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="1"
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
|
The study utilized a standard array of materials and instruments. Magic Foam Cord is chemical gingival retraction cord of polyvinyl siloxane intended to produce mechanical retraction due to its own effect on foaming intraoral setting. 3M ESPE Paste is chemical gingival retraction paste made of kaolin and aluminium chloride, yielding hamostasis, vasoconstriction, and sulcular expansion due to positive pressure. Digital Intraoral Scanner is used to obtain baseline and post- retraction contours of the soft tissues with a calibrated intraoral scanner capable of supplying high-precision digital impressions. Precise gingival retraction is of essence in successful implant-supported prosthesis production, particularly with equi-gingival and subgingival abutment margins. Cordless retraction systems such as Magic Foam Cord and 3M ESPE provide atraumatic options to conventional methods, particularly in implant cases where tissue integrity is of high importance. Aim: To compare and assess the efficacy of gingival displacement between two cordless retraction systems—Magic Foam Cord and 3M ESPE on dental implant abutments. Materials and Methods: This prospective in vivo clinical trial was conducted on 30 implant sites in 30 healthy patients in the age group of 18–40 years, who required cement-retained implant prosthesis in the posterior segments. The patients were divided into two groups (n=15 each) randomly: Group A received Magic Foam Cord and Group B received 3M ESPE paste. Digital intraoral scans were captured pre- and post-retraction using a calibrated scanner. Superimposition software was utilized to measure horizontal and vertical gingival displacement. Data were compared statistically with SPSS Version 23.0. Therefore, the aim of this study is to assess and compare the gingival
displacement effectiveness of Magic Foam Cord and 3M™ ESPE™ retraction paste
around dental implant abutments. |