Effect of Liners on Pulpal Outcome and Restoration Survival After Partial Caries Excavation

NCT03286959 | Completed DMC

• 1 other identifier: Shreyasingh
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of the study was to determine the effectiveness of cavity liners regarding survival of restoration beneath composite restoration after partial caries removal in permanent teeth with deep caries and to evaluate and compare the pulp vitality outcome both clinically and radiologically with and without liners. Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics. Mature permanent mandibular molars with deep dentinal caries and without any signs of irreversible pulpitis were included in the study. After partial excavation of caries, patients were randomly allocated into three groups- RMGIC, CH and DIRECT COMPOSITE group and were restored according to standard protocol.

Conditions

Reversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation

  CRITERIA FOR SUCCESSFUL OUTCOME The Presence of positive response to vitality tests, absence of tenderness or spontaneous pain will be considered as clinical signs of success while absence of any radiolucency in periapical or furcation region or root resorptions as radiographic signs of successful outcome. CRITERIA FOR FAILURE The presence of negative vitality tests, spontaneous pain, fistula, swelling, mobility will be considered as clinical signs of failure while presence of any radiolucency in furcation or periapical region, internal or external root resorption as radiographic signs of failure. Although the procedure of partial caries excavation will be considered fully successful only when it shows successful outcome both from maintaining pulpal vitality as per primary outcome measures and intact restoration as per secondary outcome measures described below.

  The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.

Secondary Outcomes (1)

• Evaluate and compare the effect of different liners on survival of composite restorations after partial caries excavation.

  The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.

Study Arms (3)

PCR WITH CALCIUM HYDROXIDE

ACTIVE COMPARATOR

PCR WITH CALCIUM HYDROXIDE : A layer of dycal (dentsply) was placed adjacent to pulpal or axial wall after mixing as per manufacturer recommendations followed by etching and restoration with composite using incremental technique.

Procedure: PCR with calcium hydroxide

PCR WITH RMGIC

ACTIVE COMPARATOR

PCR WITH RMGIC: A layer of resin modified liner ( GC Fuji II ) was placed adjacent to pulpal or axial wall and light cured for 40 sec. afterwards the cavity was restored with composite as in other groups.

Procedure: PCR with RMGIC

PCR WITH DIRECT COMPOSITE

ACTIVE COMPARATOR

PCR WITH DIRECT COMPOSITE: After partial caries excavation , etching and bonding was done directly without using any liner and cavity was restored with composite as in other groups

Procedure: PCR with direct composite

Interventions

PCR with calcium hydroxide PROCEDURE

Also known as: indirect pulp capping with dycal

PCR WITH CALCIUM HYDROXIDE

PCR with RMGIC PROCEDURE

Also known as: indirect pulp capping with RMGIC

PCR WITH RMGIC

PCR with direct composite PROCEDURE

Also known as: indirect pulp capping with adhesive restorations

PCR WITH DIRECT COMPOSITE

Eligibility Criteria

• Age: 14 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient willing to participate in the study.
• Mature permanent mandibular molars with deep dentinal caries involving more than half or two thirds of dentin.

You may not qualify if:

• Primary teeth.
• Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
• Immuno-compromised, diabetic, pregnant and hypertensive patients.
• Positive history of antibiotic and analgesic use.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Related Publications (1)

• Singh S, Mittal S, Tewari S. Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial. Caries Res. 2019;53(5):547-554. doi: 10.1159/000499131. Epub 2019 May 16.

  PMID: 31096259 DERIVED

MeSH Terms

Interventions

Polymerase Chain Reaction; Calcium Hydroxide; Dycal

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 19, 2017
• Study Start: November 6, 2016
• Primary Completion: January 25, 2018
• Study Completion: January 25, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share