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

Effect of Different Liners on Pulpal Outcome and Survival of Composite Restorations After Partial Caries Removal: A Randomized Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Reversible Pulpitis
• Intervention / Treatment: Procedure: PCR with calcium hydroxide; Procedure: PCR with RMGIC; Procedure: PCR with direct composite

Detailed Description

AIM AND OBJECTIVES The present study aims to

1. Evaluate the success of partial caries excavation in mandibular molar teeth.
2. Evaluate and compare the clinical and radiographic success with RMGIC, calcium hydroxide and without liners after partial caries excavation.
3. Evaluate and compare the effect of liners on restoration survival after partial caries excavation.

MATERIALS AND METHODS Study subjects were recruited from OPD of Department of conservative dentistry and endodontics, PGIDS, Rohtak.

METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out and a thorough history was taken.

Clinical procedure:

Mature mandibular permanent molars exhibiting deep caries involving more than half or two thirds of dentin were chosen for the study.

The teeth were evaluated by periapical radiographs, periodontal probing, percussion test, and vitality assessment with thermal test and electric pulp test; teeth determined to have reversible pulpitis were included and with irreversible pulpitis were excluded.

All periapical radiographs were exposed by using constant kVP, mA, and exposure time (70 KVP, 8 mA, and 0.8 sec.) with a Rinn paralleling device.

After administration of local anesthesia, rubber dam isolation of the involved tooth was done and tooth was swabbed with betadiene. Carious tissue from lateral walls and dentino enamel junction was removed completely while a layer of soft carious dentin was left adjacent to pulpal or axial wall followed by cleaning with distilled water and drying with sterile filter paper. Then the teeth were randomised into three groups using a computer generated sheet.

GROUP I CH GROUP- The pulpal or axial wall was lined by a layer of dycal as per manufacturer directions and restored with composite restoration using incremental technique.

GROUP II RMGIC GROUP - A layer of resin modified GIC was placed adjacent to pulpal or axial wall and tooth restored as above.

GROUP III DIRECT COMPOSITE GROUP- Tooth was restored with composite restorations as above without placing any liner.

FOLLOW UP- The patients were recalled periodically at 1 month, 3 months, 6 months and 12 months after the procedure for clinical (post operative sensitivity, pain, tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical radiolucency) evaluation. Also, the restoration survival was assessed using modified Hickel criteria where marginal staining, marginal adaptation, fractures and retention, secondary caries and post operative sensitivity were evaluated.

CRITERIA FOR SUCCESSFUL PULPAL OUTCOME A positive vitality test. No pain on percussion. No widening of periodontal ligament on periapical radiograph. No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.

CRITERIA FOR FAILURE No response to pulp vitality test. Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 54 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PCR WITH CALCIUM HYDROXIDE; 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; Other Names: indirect pulp capping with dycal
ACTIVE_COMPARATOR: PCR WITH RMGIC; 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; Other Names: indirect pulp capping with RMGIC
ACTIVE_COMPARATOR: PCR WITH DIRECT COMPOSITE; 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; Other Names: indirect pulp capping with adhesive restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate and compare the effect of different liners on survival of composite restorations after partial caries excavation.	Treatment outcome will be judged on the basis of clinical findings and photographs recorded at the the baseline and at follow up visits on the basis of FDI criteria as described by Hickel et al. Primary measurement variable will be restoration Retention/Fractures. But the secondary measurable variables will also be evaluated namely Marginal adaptation, Marginal staining, Postoperative sensitivity and Recurrence of caries. Scoring will range from 1( very good), 2(good, after correction very good), 3(sufficient/satisfactory, minor shortcomings), 4 (unsatisfactory, but repairable) to 5 ( poor, replacement necessary). Restorations rated 4 or 5 in one of the criteria will be classified as clinically unacceptable, excluded from further assessment and will be repaired or replaced	The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2016
• Primary Completion (ACTUAL): January 25, 2018
• Study Completion (ACTUAL): January 25, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (ACTUAL): September 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: Shreyasingh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No