Comparative evaluation of the treatment outcomes of pulpotomy in primary molars using MTA and 3Mixtatin: A randomized clinical trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- (b) Radiographic success by
Study Overview
Brief Summary
The study was conducted in the Department of Pediatric and Preventive Dentistry, ITS Dental
College, Hospital & Research Centre. 50 teeth were indicated
for pulpotomy in 52 children. After obtaining written consent from their parents /guardians,
75 the teeth were divided into two equal groups (N=25). MTA and 3Mixtatin were used in the two groups. In both the groups, pulpotomy was performed and Clinical and radiographic evaluation was done after three months, six months and at the end of one year. The overall success rates of 3Mixtatin and MTA were found to be similar and statistically insignificant over the period of 1 year follow up. At the end of the study, the following conclusion was drawn:
ï‚· no significant difference in the overall success rates of pulpotomy procedure
using MTA and 3Mixtatin over a follow-up period of one year when used for the
management of deeply carious primary teeth with no clinical/radio-graphic signs or
symptoms of irreversible pulp inflammation.
ï‚· no statistically significant difference in clinical and radiographic success of
MTA and 3Mixtatin at 3rd month, 6th month and at the end of one year.
ï‚· PDL widening was the common radiographic failure in both the groups i.e MTA and
3mixtatin.
ï‚· no clinically significant difference in the overall success rate between
maxillary and mandibular primary molars.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Clinically:
- •History of localized pain lasting for a short duration which subsides upon elimination of causative mechanical or thermal stimulus.
- •2.Carious lesions involving more than half the dentin thickness.
- •Recent History of spontaneous pain of momentary duration not exceeding 7 days.
- •Hemorrhage control achievable within 3-5 minutes during the procedure.
- •Restorable crown structure Radiographically
- •Carious lesion approximating pulp.
- •Absence of any periradicular or furcal pathology.
- •No pathologic external or internal root resorption.
Exclusion Criteria
- •Clinically:
- •History of lingering, Spontaneous and Nocturnal pain which is continuous even after removal of the stimuli.
- •Sensitivity to Hot Stimulus.
- •Tenderness on percussion.
- •Pathologic tooth mobility.
- •Vestibular obliteration and swelling in relation to the tooth
- •Draining sinus tract in relation to the tooth.
- •Grossly carious teeth with unrestorable crown structure.
- •Radiographically
- •Widened PDL space.
- •More than 1/3rd physiologic root resorption
- •Presence of periradicularor Periapical radiolucency.
- •Calcifications within pulp.
Outcomes
Primary Outcomes
(b) Radiographic success by
Time Frame: 3 months, 6 months and 12 months
Maintaining radicular pulp vitality and assessing it clinically by
Time Frame: 3 months, 6 months and 12 months
(a)Absence of spontaneous pain and/or sensitivity to percussion and palpation, fistula / swelling, pathological mobility.
Time Frame: 3 months, 6 months and 12 months
Absence of periodontal ligament space widening , radiolucency at the periapical region, internal root resorption or external root resorption.
Time Frame: 3 months, 6 months and 12 months
Secondary Outcomes
- Maintenance of tooth function and asymptomatic state(At the end of 1 year ( 12 months))