Reversible PulpitisNCT03286959
Effect of Liners on Pulpal Outcome and Restoration Survival After Partial Caries Excavation
A study testing PCR with calcium hydroxide, PCR with RMGIC and PCR with direct composite in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 54 years
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- PCR with calcium hydroxide, PCR with RMGIC and PCR with direct composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2016to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 54 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient willing to participate in the study.
- Mature permanent mandibular molars with deep dentinal caries involving more than half or two thirds of dentin.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
AIM AND OBJECTIVES The present study aims to
- Evaluate the success of partial caries excavation in mandibular molar teeth.
- Evaluate and compare the clinical and radiographic success with RMGIC, calcium hydroxide and without liners after partial caries excavation.
- 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.
- Conditions
- Reversible Pulpitis
- Being tested
- PCR with calcium hydroxide, PCR with RMGIC, PCR with direct composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR with calcium hydroxideProcedure or surgery
Also called indirect pulp capping with dycal
PCR with RMGICProcedure or surgery
Also called indirect pulp capping with RMGIC
PCR with direct compositeProcedure or surgery
Also called indirect pulp capping with adhesive restorations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Procedure: PCR with direct composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start6 Nov 2016
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286959
- Sponsor's protocol ID
- Shreyasingh
- Status last verified
- Jan 2018
- First submitted
- 8 Sep 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31096259
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Liners on Pulpal Outcome and Survival of Composite Restorations After Partial Caries Removal: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03286959
- Acronym / sponsor ID
- Shreyasingh
- Conditions
- Reversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 6 Nov 2016 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Evaluate the success of partial caries excavation in mandibular molar teeth.
- Evaluate and compare the clinical and radiographic success with RMGIC, calcium hydroxide and without liners after partial caries excavation.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCR WITH CALCIUM HYDROXIDE | Active comparator | Procedure: PCR with calcium hydroxidePCR 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. |
| PCR WITH RMGIC | Active comparator | Procedure: PCR with RMGICPCR 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. |
| PCR WITH DIRECT COMPOSITE | Active comparator | Procedure: PCR with direct compositePCR 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 |
Who may qualify
- Ages
- 14 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient willing to participate in the study.
- Mature permanent mandibular molars with deep dentinal caries involving more than half or two thirds of dentin.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR with calcium hydroxideAlso: indirect pulp capping with dycal | Procedure or surgery | PCR WITH CALCIUM HYDROXIDE |
| PCR with RMGICAlso: indirect pulp capping with RMGIC | Procedure or surgery | PCR WITH RMGIC |
| PCR with direct compositeAlso: indirect pulp capping with adhesive restorations | Procedure or surgery | PCR WITH DIRECT COMPOSITE |
Primary outcome
Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation
Time frame: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.
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.
1 secondary outcome
Evaluate and compare the effect of different liners on survival of composite restorations after partial caries excavation.
Time frame: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 31096259Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PCR with calcium hydroxide, PCR with RMGIC and PCR with direct composite in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation (time frame: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.