Reversible PulpitisNCT03284697
Direct Pulp Capping With MTA and Calcium Hydroxide.
A study testing Direct Pulp Capping with Ca(OH)2 and Direct Pulp Capping With MTA in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial summary
Aim of the study was to evaluate and compare clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars. Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Direct Pulp Capping with Ca(OH)2 and Direct Pulp Capping With MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2016to 30 Nov 2017
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient willing to participate in the study.
- Age group- 15-40 years.
- Mature permanent mandibular molars with reversible pulpitis.
- Teeth exhibiting occlusal pulp exposure from primary dental caries.
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 within past one month of the treatment.
- Failure to obtain authorization from patients.
About this study
Official title: Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth: A Randomized Clinical Study.
Aim of the study was to evaluate and compare clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.
Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics. Mature permanent mandibular molars with reversible pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective allocated material and then tooth in both groups were restored according to standard protocol.
Read the detailed description
AIM AND OBJECTIVES The present study aims to
- Evaluate the success of direct pulp capping in mandibular molar teeth.
- Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.
- To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
MATERIALS AND METHODS Study subjects were recruited from the patients visiting the Department of conservative dentistry and endodontics, PGIDS, Rohtak.
METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out.
A thorough history will be taken from each patient. Prior informed consent was obtained either from the patient or guardians after explaining the procedure, risks and benefits.
Clinical procedure:
Mature mandibular permanent molars exhibiting deep caries approaching pulp 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; the teeth determined to have reversible pulpitis were included.
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 and processed manually.
After administration of local anesthesia, rubber dam isolation of the involved tooth was done.
The tooth was disinfected by scrubbing with 2% chlorhexidine and 75% isopropyl alcohol.
Initially caries was removed with round bur under sterile water spray. Then, the remaining caries was removed carefully with a spoon excavator. After complete caries excavation, disinfection of exposed pulp with 2.5% sodium hypochlorite irrigation and a soaked cotton pellet was done.
Then sodium hypochlorite dressing was placed for 10 minutes to achieve adequate pulpal hemostasis.
Patients were randomly allocated into two groups (Group I - MTA and Group II -Calcium hydroxide) using a computer program This study was a double blinded trial i.e. both the patient and the investigator were not aware of the group to which the participant belongs.
GROUP I- CALCIUM HYDROXIDE GROUP Calcium hydroxide powder was mixed according to manufacturer's instructions and applied directly onto the exposed pulps.
The cavities were then restored with resin modified GIC liner followed by composite restoration.
GROUP II - MTA GROUP MTA was mixed according to manufacturer's instructions i.e. 1:3 water/ powder ratio and applied to exposure site with a sterile carrier.
Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed temporarily with intermediate restoration material.
After 24 hours, the patient was recalled and the setting of MTA was confirmed and the cavity was restored with resin modified GIC liner followed by composite restoration.
FOLLOW UP The patients were recalled periodically at 1 week, 3 months, 6 months and 12 months after the direct pulp capping procedure for clinical (post operative sensitivity, pain, tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical radiolucency) evaluation.
CRITERIA FOR SUCCESSFUL 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.
Postoperative pain assessment:
This was done using Horizontal VAS scale preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days after the procedure.
The pain VAS was completed by the patients themselves. The patients were asked to place a line perpendicular to the VAS line at the point that represents their pain intensity.
Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.
- Conditions
- Reversible Pulpitis
- Being tested
- Direct Pulp Capping with Ca(OH)2, Direct Pulp Capping With MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Pulp Capping with Ca(OH)2Procedure or surgery
Also called Vital Pulp Therapy
Calcium hydroxide powder was mixed with saline and placed over the exposed pulp tissue. The cavities were then restored with resin modified GIC liner followed by composite restoration.
Direct Pulp Capping With MTAProcedure or surgery
Also called Vital pulp therapy
MTA was mixed using1:3 water/ powder ratio and applied to exposure site. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed provisionally with IRM. After 24 hours, the patient was recalled and the cavity was restored with resin modified GIC liner followed by composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| DPC with Ca(OH)2 | Active comparator | Direct pulp capping with Ca(OH)2. Receives: Procedure: Direct Pulp Capping with Ca(OH)2 |
| DPC with MTA | Active comparator | Direct pulp capping with MTA Receives: Procedure: Direct Pulp Capping With MTA |
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 MTA and calcium hydroxide as direct pulp capping materials.
CRITERIA FOR SUCCESSFUL 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.
Measured: Baseline to 1 year
Secondary outcomes (1)
To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
Patients were instructed to score the pain experienced by them using VAS scale. Pain was recorded preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days following the procedure.
Pain intensity was categorized as: no pain (0 - 4 mm), mild pain (5- 44), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.
Measured: Baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start14 Oct 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- 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
- 64 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
- NCT03284697
- Sponsor's protocol ID
- Komal Suhag
- Status last verified
- Jan 2018
- First submitted
- 8 Sep 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth: A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT03284697
- Acronym / sponsor ID
- Komal Suhag
- Conditions
- Reversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 15 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 evaluate and compare clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.
Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics. Mature permanent mandibular molars with reversible pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective allocated material and then tooth in both groups were restored according to standard protocol.
Detailed description
AIM AND OBJECTIVES The present study aims to
- Evaluate the success of direct pulp capping in mandibular molar teeth.
- Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.
- To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
MATERIALS AND METHODS Study subjects were recruited from the patients visiting the Department of conservative dentistry and endodontics, PGIDS, Rohtak.
METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out.
A thorough history will be taken from each patient. Prior informed consent was obtained either from the patient or guardians after explaining the procedure, risks and benefits.
Clinical procedure:
Mature mandibular permanent molars exhibiting deep caries approaching pulp 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; the teeth determined to have reversible pulpitis were included.
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 and processed manually.
After administration of local anesthesia, rubber dam isolation of the involved tooth was done.
The tooth was disinfected by scrubbing with 2% chlorhexidine and 75% isopropyl alcohol.
Initially caries was removed with round bur under sterile water spray. Then, the remaining caries was removed carefully with a spoon excavator. After complete caries excavation, disinfection of exposed pulp with 2.5% sodium hypochlorite irrigation and a soaked cotton pellet was done.
Then sodium hypochlorite dressing was placed for 10 minutes to achieve adequate pulpal hemostasis.
Patients were randomly allocated into two groups (Group I - MTA and Group II -Calcium hydroxide) using a computer program This study was a double blinded trial i.e. both the patient and the investigator were not aware of the group to which the participant belongs.
GROUP I- CALCIUM HYDROXIDE GROUP Calcium hydroxide powder was mixed according to manufacturer's instructions and applied directly onto the exposed pulps.
The cavities were then restored with resin modified GIC liner followed by composite restoration.
GROUP II - MTA GROUP MTA was mixed according to manufacturer's instructions i.e. 1:3 water/ powder ratio and applied to exposure site with a sterile carrier.
Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed temporarily with intermediate restoration material.
After 24 hours, the patient was recalled and the setting of MTA was confirmed and the cavity was restored with resin modified GIC liner followed by composite restoration.
FOLLOW UP The patients were recalled periodically at 1 week, 3 months, 6 months and 12 months after the direct pulp capping procedure for clinical (post operative sensitivity, pain, tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical radiolucency) evaluation.
CRITERIA FOR SUCCESSFUL 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.
Postoperative pain assessment:
This was done using Horizontal VAS scale preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days after the procedure.
The pain VAS was completed by the patients themselves. The patients were asked to place a line perpendicular to the VAS line at the point that represents their pain intensity.
Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPC with Ca(OH)2 | Active comparator | Procedure: Direct Pulp Capping with Ca(OH)2Direct pulp capping with Ca(OH)2. |
| DPC with MTA | Active comparator | Procedure: Direct Pulp Capping With MTADirect pulp capping with MTA |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient willing to participate in the study.
- Age group- 15-40 years.
- Mature permanent mandibular molars with reversible pulpitis.
- Teeth exhibiting occlusal pulp exposure from primary dental caries.
Key exclusion criteria (5 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 within past one month of the treatment.
- Failure to obtain authorization from patients.
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 |
|---|---|---|
| Direct Pulp Capping with Ca(OH)2Also: Vital Pulp TherapyCalcium hydroxide powder was mixed with saline and placed over the exposed pulp tissue. The cavities were then restored with resin modified GIC liner followed by composite restoration. | Procedure or surgery | DPC with Ca(OH)2 |
| Direct Pulp Capping With MTAAlso: Vital pulp therapyMTA was mixed using1:3 water/ powder ratio and applied to exposure site. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed provisionally with IRM. After 24 hours, the patient was recalled and the cavity was restored with resin modified GIC liner followed by composite restoration. | Procedure or surgery | DPC with MTA |
Primary outcome
Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.
Time frame: Baseline to 1 year
CRITERIA FOR SUCCESSFUL 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.
1 secondary outcome
To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
Time frame: Baseline to 7 days
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 12 Jan 2018.
- 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 Direct Pulp Capping with Ca(OH)2 and Direct Pulp Capping With MTA 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 4 inclusion and 5 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 12 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 MTA and calcium hydroxide as direct pulp capping materials. (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2018.