Effectiveness Of Recent Remineralizing Agents On Defects Of Permanent Incisors.

Phase 2

Completed

Conditions: Permanent Incisors Hypoplasia

Registration Number: CTRI/2019/01/017345

Lead Sponsor: Dr Yash Shah

Brief Summary: **METHODOLOGY**

Theproposed study will be conducted as a Randomized Controlled Study. Subject selection and data collection will beinitiated after IEC approval. The purpose and nature of the study willbe explained to the participants and their parents prior to the study throughthe information sheet and informed written consent will be obtained in English/locallanguage (Gujarati) and Hindi language.

**Randomization-**Sampleswill be randomly allocated in all 4-intervention group from the population bylottery method. Total 80 chits will be prepared and Patient will be asked topick 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 abrasionremineralization (Tooth Mousse)

Group 3- Application of Micro abrasionremineralization (ToothMin)

Group 4 -Control Group (oral prophylaxis)

**Methodof Application**

**Group 1**

**Resin infiltration procedure19** isolation will be carried out with a rubber dam. Theenamel surface will be cleansed with prophylaxis paste rubbed using a rubbercup at slow speed. Then, 15% hydrochloric acid gel will be applied (ICON-Etch;DMG; Hamburg, GermanyÂ®) for 120s. Afterward, the etchant will becleansed away thoroughly for 30s. Ethanol desiccation of the lesions will bedone (ICON-Dry; DMGÂ®) for 30 s which is followed by drying.Infiltrate resin (ICON-Infiltrate; DMGÂ®) will be applied to thelesion and made to infiltrate for 3 min. The excessive material will be rubbedaway using a cotton swab before curing. Following the 40 s of light curing, theinfiltration step will be repeated again. Finally, the surface of the lesion willbe 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 withtooth Mousse9**: The initialpreparation of the teeth will be carried out with the pumice slurry and rubbercup with a slowâ€‘speed handpiece. Inthe second step, acid etching of the stained enamel surface will be carried outfor 30 s followed by rubbing with a hybrid bristled cup for another 30 s. Thethird step will involve prophylaxis with fluoridated prophylactic pastefollowed by rinsing and drying. In the last step, the application of CPP-ACP crÃ¨me(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 tothe patient. Total 3 sitting will be carried out eachat 2 weeks intervals. For home application of Tooth Mousse, Sterilecontainer and sterile ear bud in sterilized pouch will be given to patients. Tooth Mousse home application by Child will be advised underparental supervision.Standardizedclinical photographs will be taken before Micro abrasion remineralization (T1),after three sitting of Micro abrasion remineralization (T2), and 6 months afterMicro abrasion remineralization (T3).

**Group 3**

**Microabrasion Remineralization procedure with ToothMin9**: The initialpreparation of the teeth will be carried out with the pumice slurry and rubbercup with a slowâ€‘speed handpiece. Inthe second step, acid etching of the stained enamel surface will be carried outfor 30 s followed by rubbing with a hybrid bristled cup for another 30 s. Thethird step will involve prophylaxis with fluoridated prophylactic pastefollowed by rinsing and drying. Finally, the application of calcium sucrosephosphates 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 willbe carried out each at 2 weeks intervals. For home application of ToothMin,Sterile container and sterile ear bud in sterilized pouch will be given topatients. ToothMin home application by Child will be advised under parental supervision.Standardized clinicalphotographs will be taken before Micro abrasion remineralization (T1), afterthree sitting of Micro abrasion remineralization (T2), and 6 months after Microabrasion remineralization (T3).

**Group4**

**Control Group:** Those whowill be randomly allocated in group 4 will be assured that the treatment will beprovide at later stage. They will be kept under routine treatment and follow up.

oral prophylaxis will be done using prophylactic pasteand 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**

Â·        **Standardization ofphotographs**: will be done for evaluation of colour changes.

Â·        **Evaluation of colour changes:** will be done on the photographs

Â·        **Areacalculation:** will be done using grid**.**

Â·      **Photographic analysis by Co-investigator by 5points Likert scale:**

Â·      **Photographic analysis by Patient:**

Â·        **CostEffectiveness** - will be checked for treatment options.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study will present results for improvement in aesthetics.	Baseline post operative and 6 month post operative

Secondary Outcome Measures

Name	Time	Method
find which material is cost effective and which will give good clinical outcome.	Baseline Post operative and 6 month post operative

Trial Locations

Locations (1): K.M Shah Dental College And Hospital
🇮🇳
Vadodara, GUJARAT, India
K.M Shah Dental College And Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Yash Shah
Principal investigator
02668245266
yashshah6995@gmail.com