| CTRI Number |
CTRI/2019/01/017345 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness Of Recent Remineralizing Agents On Defects Of Permanent Incisors. |
|
Scientific Title of Study
|
Effectiveness of Resin Infiltration (ICON) And Micro Abrasion Remineralization Technique (MAb-Re) with Two Remineralizing Agents (Tooth Mousse and ToothMin) on Permanent Incisor Hypoplasia - A Randomized Clinical Trial |
| Trial Acronym |
REIH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yash Shah |
| Designation |
MDS 1st Year |
| Affiliation |
K.M Shah Dental College And Hospital |
| Address |
Department of Paedodontics And Preventive Dentistry
K.M Shah Dental College And Hospital
Sumandeep Vidyapeeth
At. & Po.Pipria
Ta. Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
02668245266 |
| Fax |
|
| Email |
yashshah6995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshula Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental College And Hospital |
| Address |
Department of Paedodontics And Preventive Dentistry
K.M Shah Dental College And Hospital,
Sumandeep Vidyapeeth
At. & Po.Pipria
Ta. Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
02668245266 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshula Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental College And Hospital |
| Address |
Department of Paedodontics And Preventive Dentistry
K.M Shah Dental College And Hospital,
Sumandeep Vidyapeeth
At. & Po.Pipria
Ta. Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
02668245266 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Pedodontics And Preventive Dentistry
K.M Shah Dental College And Hospital
Sumandeep Vidyapeeth
At. & Po. Piparia, Ta. Waghodia |
|
|
Primary Sponsor
|
| Name |
Dr Yash Shah |
| Address |
Department of Pedodontics And Preventive Dentistry
K.M Shah Dental College And Hospital
Sumandeep Vidyapeeth
At. & Po. Piparia, Ta. Waghodia |
| 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 Yash Shah |
K.M Shah Dental College And Hospital |
Department of Paedodontics and preventive Dentistry Room No.3
Vadodara
GUJARAT |
02668245266
yashshah6995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee(SVIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Permanent Incisors Hypoplasia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of Micro abrasion remineralization (Tooth Mousse) |
Calcium phosphopeptide (CPP), a milk derived protein, enables binding of calcium and phosphate ions, to stabilize them as amorphous calcium phosphate (ACP). This CPP-ACP can adhere intraorally to plaque pellicle, hydroxyapatite as well as soft tissues; thus, facilitating remineralization by supplying bioavailable calcium and phosphate into saliva fluids and plaque pellicle.11 Several in vitro studies have demonstrated that when CPP-ACP is placed on the tooth surface, it interacts with hydrogen ions and can diffuse into enamel to produce subsurface mineral gain. |
| Intervention |
Application of Micro abrasion remineralization (ToothMin) |
mixture of CaSPs (calcium sucrose phosphates) and inorganic calcium phosphates is also available. The technology works by creation of an aqueous solution containing high concentration of calcium (10-12%) and phosphate (8-10%) by weight without precipitation.13 ToothMin tooth cream (Micro abrasion remineralization) based on Anticay Technology having potential of re-mineralization is available in India, whose effectiveness has been shown in some in vitro studies.
(ToothMin-Abbot) |
| Intervention |
Application of Resin Infiltration (ICON-DMG) |
ICON represents an entirely new, revolutionary approach to treatment of incipient caries – a caries infiltrant. This breakthrough micro-invasive technology fills and reinforces demineralized enamel without drilling or anaesthesia. The technique of infiltration has, from the beginning, been used successfully for the treatment of non-cavitated carious lesions on smooth surfaces. |
| Comparator Agent |
Control Group |
Oral Prophylaxis with fluoridated paste |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children more than 9 years of age in which permanent incisors are erupted in the oral cavity.
2. Enamel hypoplasia Type 1 according to Silberman in 2010 category21
3. Minimum two teeth involved with Incisors hypoplasia.
4. Any lesion with isolated opacities, demarcated enamel opacities without a breakdown of the enamel, and sensitivity to external stimuli occasionally present will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having mental disabilities or systemic diseases
2. Active carious lesion
3. Previously restored tooth in question
4. Loss of the enamel, or dentin structure
5. Clinical symptoms of irreversible pulpitis.
6. Previous use of bleaching agent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will present results for improvement in aesthetics. |
Baseline post operative and 6 month post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| find which material is cost effective and which will give good clinical outcome. |
Baseline Post operative and 6 month post operative |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="49" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/02/2019 |
| Date of Study Completion (India) |
30/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
will be publishing the study in pubmed index journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
METHODOLOGY
The
proposed study will be conducted as a Randomized Controlled Study. Subject selection and data collection will be
initiated after IEC approval. The purpose and nature of the study will
be explained to the participants and their parents prior to the study through
the information sheet and informed written consent will be obtained in English/local
language (Gujarati) and Hindi language.
Randomization- Samples
will be randomly allocated in all 4-intervention group from the population by
lottery method. Total 80 chits will be prepared and Patient will be asked to
pick any one chit from the bowl.
Receptionist will be note down the enrollment in the decoding chart.
Group 1- Application of Resin Infiltration (ICON)
Group 2- Application of Micro abrasion
remineralization (Tooth Mousse)
Group 3- Application of Micro abrasion
remineralization (ToothMin)
Group 4 -Control Group (oral prophylaxis)
Method
of Application
Group 1
Resin infiltration procedure19 isolation will be carried out with a rubber dam. The
enamel surface will be cleansed with prophylaxis paste rubbed using a rubber
cup at slow speed. Then, 15% hydrochloric acid gel will be applied (ICON-Etch;
DMG; Hamburg, Germany®) for 120s. Afterward, the etchant will be
cleansed away thoroughly for 30s. Ethanol desiccation of the lesions will be
done (ICON-Dry; DMG®) for 30 s which is followed by drying.
Infiltrate resin (ICON-Infiltrate; DMG®) will be applied to the
lesion and made to infiltrate for 3 min. The excessive material will be rubbed
away using a cotton swab before curing. Following the 40 s of light curing, the
infiltration step will be repeated again. Finally, the surface of the lesion will
be polished using polishing discs for composites.
Standardized clinical photographs will be taken before infiltration (T1),
immediately after infiltration (T2), and 6 months after infiltration (T3).
Group 2
Micro abrasion Remineralization procedure with
tooth Mousse9: The initial
preparation of the teeth will be carried out with the pumice slurry and rubber
cup with a slow‑speed handpiece. In
the second step, acid etching of the stained enamel surface will be carried out
for 30 s followed by rubbing with a hybrid bristled cup for another 30 s. The
third step will involve prophylaxis with fluoridated prophylactic paste
followed by rinsing and drying. In the last step, the application of CPP-ACP crème
(GC tooth mousse) on treated tooth surface, which will be left there for 4 min.
Home application of GC tooth mousse thrice daily for 2 weeks will be advised to
the patient. Total 3 sitting will be carried out each
at 2 weeks intervals. For home application of Tooth Mousse, Sterile
container and sterile ear bud in sterilized pouch will be given to patients. Tooth Mousse home application by Child will be advised under
parental supervision. Standardized
clinical photographs will be taken before Micro abrasion remineralization (T1),
after three sitting of Micro abrasion remineralization (T2), and 6 months after
Micro abrasion remineralization (T3).
Group 3
Micro
abrasion Remineralization procedure with ToothMin9: The initial
preparation of the teeth will be carried out with the pumice slurry and rubber
cup with a slow‑speed handpiece. In
the second step, acid etching of the stained enamel surface will be carried out
for 30 s followed by rubbing with a hybrid bristled cup for another 30 s. The
third step will involve prophylaxis with fluoridated prophylactic paste
followed by rinsing and drying. Finally, the application of calcium sucrose
phosphates and inorganic calcium phosphates (ToothMin) treated tooth surface,
which will be left there for 4 min. Home application of ToothMin (abbott)
thrice daily for 2 weeks will be advised to the patient. Total 3 sitting will
be carried out each at 2 weeks intervals. For home application of ToothMin,
Sterile container and sterile ear bud in sterilized pouch will be given to
patients. ToothMin home application by Child will be advised under parental supervision.
Standardized clinical
photographs will be taken before Micro abrasion remineralization (T1), after
three sitting of Micro abrasion remineralization (T2), and 6 months after Micro
abrasion remineralization (T3).
Group4
Control Group: Those who
will be randomly allocated in group 4 will be assured that the treatment will be
provide at later stage. They will be kept under routine treatment and follow up.
oral prophylaxis will be done using prophylactic paste
and follow up after 6 months will be carried out.
Standardized clinical photographs will be taken before Oral Prophylaxis (T1),
after Oral prophylaxis (T2), and 6 months after Oral prophylaxis (T3).
Method of evaluation
·
Standardization of
photographs: will be done for evaluation of colour changes.
·
Evaluation of colour changes: will be done on the photographs
·
Area
calculation: will be done using grid.
· Photographic analysis by Co-investigator by 5
points Likert scale:
· Photographic analysis by Patient:
·
Cost
Effectiveness - will be checked for treatment options.
|