Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

Pulpitis - Irreversible Clinical Trial

Official title:

Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406557
• Other study ID #: DR. A RAMANI
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

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