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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05406557
Other study ID # DR. A RAMANI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2022
Est. completion date July 2023

Study information

Verified date May 2022
Source Postgraduate Institute of Dental Sciences Rohtak
Contact DR. ANKITA RAMANI, MDS
Phone +919582841539
Email ramaniankita95@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis


Description:

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in same appointment. Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 6 and 12 months from baseline.


Recruitment information / eligibility

Status Recruiting
Enrollment 86
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - The patient with18 -45 years of age. - Restorable molar teeth. - Tooth should give positive response to pulp sensibility testing. - Clinical diagnosis of symptomatic partial irreversible pulpitis. - Tooth with probing pocket depth and mobility are within normal limits. - No signs of pulpal necrosis including sinus tract or swelling. - Non-contributory medical history Exclusion Criteria: - Teeth with immature roots. - No pulp exposure after caries excavation. - Bleeding could not be controlled in 6 minutes. - Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Partial pulpotomy
In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of pulp chamber.
Miniature pulpotomy
In case of miniature pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of only affected pulp horn

Locations

Country Name City State
India Dr. Ankita Ramani Rohtak Haryana

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical and radiographic success Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.
RADIOGRAPHIC SUCCESS CRITERIA:
No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.
Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique.
Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
Baseline to 12 Months
Secondary Pain analysis To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain Baseline to 7 days
Secondary Pulp sensibility testing To assess pulp tissue response using cold and electric pulp test at 6 and 12 months Baseline to 12 months
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