Ignite Creation Date:
2024-05-06 @ 10:32 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03284697
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2017-09-08
Brief Title:
Direct Pulp Capping With MTA and Calcium Hydroxide
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth A Randomized Clinical Study
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
1 Evaluate the success of direct pulp capping in mandibular molar teeth
2 Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials
3 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 08 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 25 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 ie 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 manufacturers 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 manufacturers instructions ie 13 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 andor symptoms of irreversible pulpitis and pulp necrosis
CRITERIA FOR FAILURE No response to pulp vitality test Teeth exhibiting clinical or radiographic signs andor 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 mg6-8h 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
1 Evaluate the success of direct pulp capping in mandibular molar teeth
2 Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials
3 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 08 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 25 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 ie 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 manufacturers 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 manufacturers instructions ie 13 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 andor symptoms of irreversible pulpitis and pulp necrosis
CRITERIA FOR FAILURE No response to pulp vitality test Teeth exhibiting clinical or radiographic signs andor 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 mg6-8h 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None