Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

Not Applicable

• Conditions: Caries
• Interventions: Procedure: Selective caries removal; Procedure: Stepwise caries removal

• Registration Number: NCT04375215
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.

Detailed Description

The patient will be selected as per the pre-defined eligibility criteria. Written informed consent will be taken from each consenting participant. Initial caries excavation will be done under rubber dam isolation. The patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. Composite restoration with glass ionomer liner will be then placed in both groups. Additional complete caries excavation will be done in the stepwise caries removal group after six months.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-04-24
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-03
• Last Update Submitted: 2020-05-03
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05
• Primary Completion: 2021-04-30
• Study Completion: 2021-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Outpatient in age range of 18yr-60yr
• Permanent mandibular posterior teeth with deep caries
• Caries extending to >3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph
• Positive response to cold test and electric pulp test

Exclusion Criteria

• Any general disease affecting the caries e.g. patient under head and neck radiotherapy
• Patients with immuno-compromised status
• Tooth with fracture line, cracks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selective caries removal to soft dentin (one step)	Selective caries removal	In selective caries removal to soft dentine, after caries excavation application of liner will be done on pulpal floor. Teeth will then be filled with composite resin material.
Stepwise caries removal (two step)	Stepwise caries removal	The stepwise caries removal is a two step procedure. The first step is similar to selective caries removal to soft dentin group. In the second step, after 6 months lesion will be re-entered to remove remaining carious tissue till firm dentin is encountered. Once all the caries is removed from floor of cavity a liner followed by final restoration with composite will be performed.

Primary Outcome Measures

Name	Time	Method
Clinical success	Baseline to 12 months	Clinical success will be judged by following criteria; * Positive response on vitality test.; * Absence of pain on percussion and any other signs and/or symptoms of irreversible pulpitis and pulp necrosis; Criteria for failure will be; * Negative response on pulp vitality test.; * Tenderness to percussion and teeth exhibiting any clinical signs and/or symptoms of irreversible pulpitis and pulp necrosis.

Secondary Outcome Measures

Name	Time	Method
Radiographic Success	Baseline to 12 months	Absence of periapical alterations (radiolucency at furcal or periapical region).

Trial Locations

Locations (1)

Post Graduate Institute of Dental Science; 🇮🇳 Rohtak, Haryana, India