Clinical And Radiological Comparison of Pro Root MTA, TheraCal LC, TheraCal PT As Direct Pulp Capping Agent

Not yet recruiting

Conditions: Dental caries on pit and fissure surface,

Registration Number: CTRI/2023/02/049703

Lead Sponsor: Dr Radhika Charhate

Brief Summary: Direct pulp capping (DPC) is a clinical procedure involving the placement of a biomaterial which aims to maintain dental pulp vitality by stimulating the formation of tertiary dentin as a hard-tissue barrier protector. Although many previous studies have done on Pro Root MTA and TheraCal LC as a direct pulp capping agent, but there is limited data available regarding MTA, TheraCal LC and TheraCal PT as a direct pulp capping agent.

Group A (Pro Root MTA group)- MTA will be mixed according to manufacturerâ€™s instructions (i.e., 1:3 water / powder ratio) and applied over an exposed site with a sterile carrier. Cotton pellet soaked in normal saline will be placed over MTA and the cavity will be sealed temperorily with intermediate restorative material Orafil G (prevest denpro, jammu and kashmir, india), after 24 hours the setting of MTA will be evaluated and direct composite restoration tetric n-ceram and tetric n-bond self-etch, (ivoclar vivadent, india) will be placed.

Group B (TheraCal LC) -TheraCal LC will be delivered at the exposure site according to the manufacturerâ€™s instructions. Resin Modified Glass Ionomer Cement (RMGIC) will be placed and patient will be recall after 3 days for permanent restoration with Composite (Tetric n-ceram, Ivoclar Vivadent, India) restoration.

Group C (TheraCal PT) -TheraCal PT will be delivered at the exposure site according to the manufacturerâ€™s instructions. Resin Modified Glass Ionomer Cement (RMGIC) will be placed and patient will be recall after 3 days for permanent restoration with Composite (Tetric n-ceram, Ivoclar Vivadent, India) restoration. The patients will be recall for Clinical and Radiological evaluation after 1,6,12 months intervals.

Clinical evaluation will be perfomed at 1st,6th and 12th months after DPC for history of spontaneous pain, sensibility status of teeth, discoloration of teeth, restoration status, surface texture, anatomic form, secondary caries, post-operative sensitivity, marginal discoloration and marginal integrity.

Radiographic evaluation will be perfomed at 1st,6th and 12th months. After 1 st,6 th and 12th months of direct pulp capping, digital periapical radiographs will be taken and submitted to image analysis CoralDRAW X7 Software (coral corporation, Ontario, Canada) 1 st - and 6 th -month radiographs will be overlapped. Radiographs will be adjusted in the software to fit in the measurement of 41 mm Ã—31mm.Qualitative assessment of the radiograph will be done to find whether the reparative dentin is visible or not.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

deep carious lesion, healthy co-operative patient, caries to the occlusal surface, Positive response to thermal and electric pulp tests,Sensitivity to cold food,.No radiographic evidence of periapical pathology.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct	To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct \| pulp capping agent in carious permanent teeth after 1st,6th \| ,12th month interval.
pulp capping agent in carious permanent teeth after 1st,6th	To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct \| pulp capping agent in carious permanent teeth after 1st,6th \| ,12th month interval.
,12th month interval.	To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct \| pulp capping agent in carious permanent teeth after 1st,6th \| ,12th month interval.

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare radiologically Pro Root MTA, Theracal LC and Theracal PT as a direct pulp capping agent in carious permanent tooth after 1st,6th,12th month interval.	To evaluate and compare radiologically Pro Root MTA, Theracal LC and Theracal PT as a direct pulp capping agent in carious permanent tooth after 1st,6th,12th month interval.

Trial Locations

Locations (1): Swargiya dadasaheb kalmegh smruti dental college and hospital nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
Swargiya dadasaheb kalmegh smruti dental college and hospital nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Dr Radhika Charhate
Principal investigator
9588469297
radhikacharhate445@gmail.com