Comparative evaluation of Bio-C Repair and Biodentine as pulpotomy agents in primary molars: A clinical study.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- DR KRUTHI H G
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To clinically and radiographically evaluate Bio-C repair as a pulpotomy agent and compare it with that of Biodentine in primary molars.
Overview
Brief Summary
Sixty primary molars will be allocated by simple randomization technique to two groups of 30 teeth each:
Group(I) : Bio-C repair (Angelus, Londrina, PR, Brazil).
Group (II): Biodentine (Septodont, Saint-Maur-des-Fosses, France).
The tooth will be anaesthetized using 2% lignocaine hydrochloride containing adrenaline at a concentration of 1:80000 and will be isolated using rubber dam. Dental caries and overhanging enamel will be removed with a #330 high speed bur with water spray and access to coronal pulp will be gained. The entire roof of the pulp chamber will be removed and coronal pulp will be amputated with a sterile sharp discoid spoon excavator until the root canal orifices are seen, with no tags remaining on the pulpal floor. Haemorrhage will be controlled using slightly moistened cotton pellets placed on the pulp stumps at the orifices of the root canal. Following the achievement of hemostasis,
Group(I): Bio-C repair will be mixed as per manufacturer’s instructions and will
be placed on the floor of the pulp chamber.
Group (II): Biodentine will be mixed as per manufacturer’s instructions and will be
placed on the floor of the pulp chamber.
In both groups, all the teeth will be restored with a type II glass ionomer cement (Shofu, Shofuinc, Japan) and composite resin (Tetric-N-flow Bulk Fill, Ivoclar, Vivadent, Schaan, Liechtenstein). An immediate postoperative intra oral periapical radiograph will be taken. Stainless steel crowns will be placed within 1 week of the restoration. Patients will be recalled after 1, 3, 6 and 12 month intervals for clinical evaluation. The radiographic evaluation will be done at the end of one year according to the following criteria2:
Clinical criteria:
-
Symptoms of pain.
-
Tenderness on percussion.
-
Presence of swelling.
-
Presence of fistula or sinus.
-
Pathological mobility.
Radiographic criteria:
-
Periodontal ligament space widening.
-
Periapical radiolucency.
-
Furcal radiolucency.
-
Internal resorption.
-
External resorption.
Data obtained will be subjected to statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 9.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy cooperative patient.
- •Absence of pulp degeneration.
- •Absence of spontaneous or persistent pain.
- •Absence of abscess and intraoral sinus.
- •Presence of two-third of root.
Exclusion Criteria
- •History of spontaneous pain.
- •Presence of swelling or sinus tract.
- •Tooth with preshedding mobility.
- •Evidence of pathological internal/ external resorption of root.
- •Pathological tooth mobility.
- •Presence of furcation and interradicular radiolucency.
Outcomes
Primary Outcomes
To clinically and radiographically evaluate Bio-C repair as a pulpotomy agent and compare it with that of Biodentine in primary molars.
Time Frame: one and half year.
Secondary Outcomes
No secondary outcomes reported
Investigators
DR KRUTHI H G
The Oxford Dental College