Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment

Not Applicable

• Conditions: Irreversible Pulpitis
• Interventions: Procedure: root canal treatment; Procedure: Pulpotomy

• Registration Number: NCT05190406
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

Detailed Description

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-28
• Status Verified: 2022-01
• Study First Posted: 2022-01-13
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-07-31
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Mature permanent restorable mandibular molar teeth.
• Tooth should give positive response to pulp sensibility testing.
• Clinical diagnosis of irreversible pulpitis with PAI score≤2.
• Tooth with probing pocket depth and mobility are within normal limits.
• 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.
• Absence of antagonist tooth.
• Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
• Had taken analgesic in past 3 days.
• Tooth with periapical lesion visible on radiograph

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Root canal treatment	root canal treatment	Single visit root canal treatment will be done according to standard protocol.
Pulpotomy	Pulpotomy	complete pulpotomy will be done till the level of root canal orifice.

Primary Outcome Measures

Name	Time	Method
Radiographic success rate	6 months and one year	Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2
Clinical success rate	6 months and one year	Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.

Secondary Outcome Measures

Name	Time	Method
Pain assessment	baseline to one week	Visual analogue Scale of 0 to 10 Centimetere line will be used to assess pain. Score 0 means no pain and Score 10 means maximum pain.
Oral Health related quality of Life	baseline to one week, 6 months and one year	Oral Health Impact Profile-14 questionnaire of score 0-4 will be used to assess the quality of life. Score 0 means never and 4 means very often affected the quality of life.

Trial Locations

Locations (1)

Post graduate institute of dental sciences; 🇮🇳 Rohtak, Haryana, India