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Clinical Trials/CTRI/2024/07/071398
CTRI/2024/07/071398
Completed
Not Applicable

Clinical and radiographic evaluation of biodentine and low level laser therapy for full pulpotomy in permanent teeth- A randomized controlled trial

Meba Merin Joy1 site in 1 country32 target enrollmentStarted: August 12, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Meba Merin Joy
Enrollment
32
Locations
1
Primary Endpoint
Clinical and Radiographic evaluation at 6 months interval

Overview

Brief Summary

This study is a randomized controlled trial evaluating the clinical and radiographic symptoms in full pulpotomy with and without photobiomodulation using low level laser therapy at 3 months and 6 months interval. Following the inclusion and exclusion criteria and obtaining consent from the patients, they will be divided into two groups. in both the groups, caries will be excavated and coronal access will be made under rubber dam isolation.  Primary hemostasis is obtained using 2.5% sodium hypochlorite within 5 minutes. In Group A, 2-3mm thick layer of Biodentine (Septodont, France) is mixed and placed according to manufacturer’s instruction, followed by a layer of resin modified glass ionomer cement and permanent restoration using composite. In Group B, the root canal orifice will be exposed to Diode laser (SiroLaser Blue, Densply Sirona) of 660nm in continuous mode of application for approximately 60 seconds which will be kept at 1-2mm distance at 200 mW power. Both  the operator and the patient will be wearing protective eyewear during the laser application. The rest of the procedures are the same as Group A. Patients will be assessed for clinical symptoms after 24 hours and after 1 week. The primary outcome is the clinical and radiographic analysis which will be done at 3 months and 6 months interval. The patients will be clinically assessed for sensitivity, pain, tender on percussion, draining sinus, swelling and mobility. The radiographic changes such as periodontal ligament space widening, periapical radiolucency, furcal lesion, internal and external root resorption will be assessed. Success will be determined by the absence of symptoms. If failure is diagnose, the tooth will be endodontically treated.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 30.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Systemically healthy patients between 18 and 30 years of age Permanent mandibular first and second molar with mature roots Dental caries extending greater than or equal to 2/3rd of dentine or exposing the pulp on the radiograph Clinical diagnosis of irreversible pulpitis with no periapical changes in the radiograph Bleeding should be controlled in 5 minutes following pulpotomy Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.

Exclusion Criteria

  • Presence of sinus tract or swelling No pulp exposure after caries excavation Teeth with radiographic signs of internal resorption Pregnant and lactating mothers.

Outcomes

Primary Outcomes

Clinical and Radiographic evaluation at 6 months interval

Time Frame: 6 months

Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling and mobility

Time Frame: 6 months

Radiographic evaluation of periodontal ligament space widening, periapical radiolucency, furcal lesion, internal or external root resorption

Time Frame: 6 months

Secondary Outcomes

  • Clinical & Radiographic evaluation at 3 months interval(Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling & mobility)
  • Clinical symptoms(Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling & mobility)

Investigators

Sponsor
Meba Merin Joy
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Meba Merin Joy

Bapuji Dental College and Hospital

Study Sites (1)

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