| CTRI Number |
CTRI/2024/11/076756 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Application of Graphene oxide as a pulp capping material in dentistry |
|
Scientific Title of Study
|
Comparative evaluation of the clinical efficacy of indirect pulp capping procedure of graphene oxide nanoparticles with calcium hydroxide: A clinical 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 |
Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences
Conservative Dentistry and Endodontics,
MCODS,
Light House Hill Road Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Yash Waman Kamath |
| Designation |
Student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences
Conservative Dentistry and Endodontics,
MCODS,
Light House Hill Road Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9029050881 |
| Fax |
|
| Email |
meechyash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences
Conservative Dentistry and Endodontics,
MCODS,
Light House Hill Road Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| H 21 Gopalpur, Jamshedpur, Jharkhand 832102, INDIA |
| Manipal College of Dental Sciences, Light House hill road, Mangalore 575001,India |
|
|
Primary Sponsor
|
| Name |
Nano research Lab |
| Address |
H-21 Gopalpur Jamshedpur Jharkhand,832102 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Yash Waman Kamath |
Manipal College of Dental Sciences |
Room no. 3, Manipal College of Dental Sciences
Light House Hill Road, Hampankatta, Mangalore, 575001 ,India
Dakshina Kannada
KARNATAKA |
9029050881
meechyash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manipal College of Dental Sciences Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide |
Trade name being Dycal present in two paste form (base paste and catalyst paste) will be applied on the tooth surface as indirect pulp capping agent and will be followed up for a period of 6 months and 1 year |
| Intervention |
Graphene oxide |
Reduced Graphene Oxide with the purity of 96-99% will be applied on the tooth surface as indirect pulp capping agent and followed up for a period of 6months and 1 year |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Class I carious lesions without any periapical changes |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients
Symptomatic patients with periapical and periradicular lesions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Graphene oxide to be used as indirect pulp capping agent in the tooth. To evaluate the outcome of the indirect pulp capping procedure using Graphene oxide by comparing the pre – and post – operative pain by using VAS scale pre- and post- operative symptoms such as presence of swelling, intraoral sinus, tender on percussion and any other if any. |
Baseline, 4weeks and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcome of the indirect pulp capping procedure using graphene oxide by comparing the pre & post operative changes in intraoral periapical radiograph using periapical index. (Paralleling technique) |
1month, 3months, 6months, 12months |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
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
|
Caries affecting the teeth results in irreversible damage. If left untreated it can affect the pulp and cause pulpal disease. This study aims at restricting the carious process and helping in the formation of reparative dentin with the help of graphene oxide. |