evaluation of three different materials as base under restoration in deeply carious milk teeth clinically and radiographically

Completed

• Conditions: healthy children aged between 4 to 10 years who are indicated for dental indirect pulp capping treatment; Dental caries, unspecified,

• Registration Number: CTRI/2020/12/029578
• Lead Sponsor: dr durga r

Brief Summary

**INTRODUCTION**

Indirect pulp treatment (IPT) or indirect pulp capping (IPC) is recommended for teeth that have deep carious lesions approximating the pulp with no signs or symptoms of pulp degeneration. This technique has been derived with the ideology that the dental pulp possesses the ability to form a dentin-like matrix (tertiary dentin) as a part of the repair in the dentin-pulp complex. Calcium hydroxide has been a gold standard for pulp capping. Various disadvantages have been witnessed with calcium hydroxide when followed up for longer times which has led to the use of various materials for IPC including glass ionomer cement and adhesives and more recently mineral trioxide aggregate (MTA), and biodentine.

**AIM AND OBJECTIVE:**

1.     Toassess and compare, the success rate of indirect pulp treatment in primary teeth using mineral trioxide aggregate (MTA), Biodentine, silver diamine fluoride (SDF) as capping agents clinically.

2.     To determine and compare the radiological changes in terms of quantity and quality of tissue formed under these capping materials in primary teeth

 **MATERIAL AND METHOD:**

In a randomized control trail, 60 patients aged between 4-10 years, will be randomly allocated in three groups, group 1- MTA, group 2- Biodentine, and group 3- silver diamine fluoride. Procedure involves satisfactory removal of infected dentine, then one of the test material will be applied at the base of the cavity, and definitive restoration (closed sandwich technique) will be done on the same day. An immediate Postoperative Cone Beam Computer Tomography scan will be performed on the same day for baseline data. Standard procedural protocol shall be followed for isolation, technique, and material manipulation. Patient will not be allowed to eat for 1 hours postoperative. Each tooth will be followed up at 8 weeks, 6 month, 12 month for observation of clinical outcome and radiographical changes in thickness and type of dentine formed beneath the test material. To identify the thickness and type of dentine another CBCT will be performed at 6th month follow up visit. At the end of the study, the data obtained from all the groups will be summarized collectively and subjected to statistical analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Study Completion: 2022-09-17
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinically 1)Children between the age group of 4 to 10 years.
• 2)Teeth with deep caries on the occlusal or proximal surfaces with history of dull reversible pain or mild discomfort on chewing 3)Sensitivity to hot, cold, and sweet lasting not more than 15 to 20 sec.
• Radiographically 1)Caries depth greater than two-third of dentine thickness approaching pulp 2)No radiolucency in periapical or furcational area of teeth.

Exclusion Criteria

1)Teeth with periodontal lesions/ Pathological mobility 2)Teeth near to exfoliation 3)Non restorable teeth 4)Teeth more than half root resorption 5)Dull throbbing pain, sharp spontaneous pain, or pain exacerbated by lying down 6)Sensitivity to palpation or percussion 7)Discolored teeth 8)Radiolucency in periapical and/or furcation area of teeth 9)Un- cooperative patients who cannot be managed by non-pharmocological behavior management techniques.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
variation in dentin depth at post op. and 6 month time in the standard group out of the three study groups.	8 weeks, 6 months, 1 year.

Secondary Outcome Measures

Name	Time	Method
clinical and radiographic success rate of the three different pulp capping agents in three grops based on the evaluation crieteria	at 8th week, 6 month and 1 year follow-up

Trial Locations

Locations (1)

king georges medical university; 🇮🇳 Lucknow, UTTAR PRADESH, India

king georges medical university

🇮🇳Lucknow, UTTAR PRADESH, India

r durga

Principal investigator

8939226879

rdurgabds@gmail.com