Clinical trial NCT03286959: Effect of Liners on Pulpal Outcome and Restoration Survival After Partial Caries Excavation
Official title: Effect of Different Liners on Pulpal Outcome and Survival of Composite Restorations After Partial Caries Removal: A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reversible Pulpitis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 198
Sex: ALL
Minimum age (years): 14
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation
timeFrame: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.
Secondary outcomes:
measure: Evaluate and compare the effect of different liners on survival of composite restorations after partial caries excavation.
timeFrame: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.