Trial Outcomes & Findings for Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy. (NCT NCT05853185)

Results Overview

Number of participants with clinical success based on following criteria * No complaints of pain or discomfort outside of the initial two days following therapy. * The tooth shows no signs of pain upon palpation or percussion. * A probing pocket depth of less than 4 mm and 1 mm are indicative of normal movement. * No inflammation or sinus tract can be seen in the soft tissues around the teeth.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

6 Months

Results posted on

2023-08-24

Participant Flow

Department of Operative Dentistry \& Endodontics, Liaquat University of Medical and Health Sciences, Jamshoro

All participants fulfilling the inclusion criteria consented for the study.

Participant milestones

Participant milestones
Measure	Pro Root MTA® Patients in this group will receive the pulpotomy with Pro Root MTA®. Pro Root MTA®: Patients in this group will receive the pulpotomy with Pro Root MTA®.	EBRRM® Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. EBRRM®: Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pro Root MTA® n=32 Participants Patients in this group will receive the pulpotomy with Pro Root MTA®. Pro Root MTA®: Patients in this group will receive the pulpotomy with Pro Root MTA®.	EBRRM® n=32 Participants Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. EBRRM®: Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.	Total n=64 Participants Total of all reporting groups
Age, Continuous	30.19 Years STANDARD_DEVIATION 10.548 • n=32 Participants	31.25 Years STANDARD_DEVIATION 11.322 • n=32 Participants	30.72 Years STANDARD_DEVIATION 10.868 • n=64 Participants
Sex: Female, Male Female	16 Participants n=32 Participants	9 Participants n=32 Participants	25 Participants n=64 Participants
Sex: Female, Male Male	16 Participants n=32 Participants	23 Participants n=32 Participants	39 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Pakistan	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Clinical Outcome Success at 6 months

Number of participants with clinical success based on following criteria * No complaints of pain or discomfort outside of the initial two days following therapy. * The tooth shows no signs of pain upon palpation or percussion. * A probing pocket depth of less than 4 mm and 1 mm are indicative of normal movement. * No inflammation or sinus tract can be seen in the soft tissues around the teeth.

Outcome measures

Outcome measures
Measure	Pro Root MTA® n=32 Participants Patients in this group will receive the pulpotomy with Pro Root MTA®. Pro Root MTA®: Patients in this group will receive the pulpotomy with Pro Root MTA®.	EBRRM® n=32 Participants Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. EBRRM®: Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Clinical Success at 6 Months	27 Participants	30 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Patients with no radiographic findings at 6 months

Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph

Outcome measures

Outcome measures
Measure	Pro Root MTA® n=32 Participants Patients in this group will receive the pulpotomy with Pro Root MTA®. Pro Root MTA®: Patients in this group will receive the pulpotomy with Pro Root MTA®.	EBRRM® n=32 Participants Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. EBRRM®: Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Radiographic Success	30 Participants	32 Participants

Adverse Events

Pro Root MTA®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EBRRM®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarang Suresh

Liaquat University of Medical and Health Sciences

Phone: 03154044802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place