| CTRI Number |
CTRI/2018/05/013674 [Registered on: 04/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of dental fluorosis using combined techniques |
|
Scientific Title of Study
|
ESTHETIC MANAGEMENT OF FLUOROSED TEETH USING RESIN INFILTRATION TECHNIQUE ALONE AND IN COMBINATION WITH ENAMEL MICROABRASION AND MCINNES BLEACHING: A RANDOMIZED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PUNAMALLI SYMON PRASANTH |
| Designation |
MDS |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003.
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9032783499 |
| Fax |
|
| Email |
punamalli.prasanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Chandra sekhara Reddy |
| Designation |
Professor and Head of the Department |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003.
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9246482426 |
| Fax |
|
| Email |
dr.chandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PUNAMALLI SYMON PRASANTH |
| Designation |
MDS |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003.
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9032783499 |
| Fax |
|
| Email |
punamalli.prasanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. punamalli symon prasanth
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
Andhra pradesh,
524003. |
|
|
Primary Sponsor
|
| Name |
Dr Punamalli Symon Prasanth |
| Address |
Narayana Dental College And Hospital,
Chintareddy palem,
Nellore-3,
andhra pradesh,
524003. |
| 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 punamalli symon prasanth |
,Narayana Dental College and Hospital |
Department Of Public Health Dentistry
3 rd floor
Room No;9
Nellore
ANDHRA PRADESH |
9032783499
punamalli.prasanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Narayana Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dental fluorosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enamel micro abrasion and resin infiltration |
An approximately 6 mm thick layer of 6.6%HCl slurry with silicon carbide particles was applied over the defective areas of the tooth with a special rubber that has flutted edges.Tooth was treated for 2 min as per amnufacturere instructions and rinsed with water for 10-15 sec and dried with compressed air
5. This technique is followed by resin infiltration technique
Application of etchant gel: 15% hydrochloric acid was applied on the lesion as an etchant gel with an applicator. After 2 minutes gel was washed thoroughly
Application of Alcohol liquid: : 95%-100%ethanol was applied for 30 seconds on the lesion as a drying agent.
Application of resin infiltrate: Triethylene-glycol dimethacrylate was applied on the lesion and allowed to penetrate for 3 minutes and then polymerized for 30 seconds |
| Intervention |
McInnes bleaching with resin infitration |
A fresh solution of bleaching mixture was prepared for each patient in dappen dish. The mixture consists of 1ml of 36% HCL, 1ml of 30% H2O2,0.2ml of diethyl ether.
Bleaching mixture was applied over the area of discoloration present on facial surface of tooth and allowed to be contact for 3 minutes. The bleaching solution is neutralized with baking soda solution and copious irrigation with water.
This technique is followed by resin infiltration technique
Application of etchant gel: 15% hydrochloric acid was applied on the lesion as an
etchant gel with an applicator. After 2 minutes gel was washed thoroughly Application of Alcohol liquid: 95%-100%ethanol was applied for 30 seconds on the lesion as a drying agent.
Application of resin infiltrate: Triethylene-glycol dimethacrylate was applied on the lesion and allowed to penetrate for 3 minutes and then polymeried for 30 sec |
| Comparator Agent |
resin infiltration, |
Application of etchant gel: 15% hydrochloric acid was applied on the lesion as an etchant gel with an applicator. After 2 minutes gel was washed thoroughly
Application of Alcohol liquid: 95%-100%ethanol was applied for 30 seconds on the lesion as a drying agent.
Application of resin infiltrate: Triethylene-glycol dimethacrylate was applied directly on dried white mark and allowed to penetrate for 3 min and tooth is light cured for 30 sec |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Patients aged 15 and above with mild to moderate degree of fluorosis on maxillary
anterior teeth (Deans score 2-3)and who are willing to participate in the study and who will give written consent will be included.
Patients with no signs of dental caries or restorations on maxillary anterior teeth. Patients who are ready to cooperate during the study period and attend periodic
recalls |
|
| ExclusionCriteria |
| Details |
Any fixed orthodontic appliances or prosthesis
Fractured maxillary anterior teeth
Carious and grossly decayed teeth
Non fluoride stains
Smoking habit and tobacco chewing
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual analog scale, schiff sensitity scale |
immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual analog scale, schiff sensitity scale |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/01/2018 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This randomized clinical trail was conducted for the treatment of dental fluorosis using resin infiltration technique alone and in combination with enamel microabrasion and Mc Innes bleaching for a duration of 6 months in 30 patients in Narayana Dental; college Nellore, Andhra Pradesh, India. The primary out comes was assessed immediately after treatmment using using VAS scale and schiff sensitvity scale, secondary outcomes will be assesed after 6 months. |