Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

Pulpitis - Irreversible Clinical Trial

Official title:

Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04397315
• Other study ID #: Dr. Ankita Ramani
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis

Description:

After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of 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 Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA 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 second 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 success at every 3 months from baseline to 1 year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria: Inclusion criteria

• The patient should be =18 years of age.

• Restorable molar teeth.

• Tooth should give positive response to pulp sensibility testing.

• Clinical diagnosis of 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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Pulpotomy to the level of canal orifices
Pulp tissue will be removed till the level of canal orifices.
• Pulpotomy up to superficial 2-3 mm of pulp chamber
Only superficial pulp from the chamber will be removed

Locations

Country	Name	City	State
India	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 Success and radiographic success	CLINICAL SUCCESS CRITERIA: 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 10 Centimetere line. Score 0 means no pain and Score 10 means maximum pain.	Baseline to 7 days