Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

Caries Clinical Trial

Official title:

Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375215
• Other study ID #: VISHALPGIDS
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: May 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: June 15, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Dental Caries

Intervention

Procedure:
• Selective caries removal
After caries removal restoration of tooth will be performed
• Stepwise caries removal
After caries removal restoration of tooth will be performed

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Science	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	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.	Baseline to 12 months
Secondary	Radiographic Success	Absence of periapical alterations (radiolucency at furcal or periapical region).	Baseline to 12 months