Treatment success and pain after removal of the dental pulp: comparison of two dental cements used in public care

Clinical Success Rate and Absolute Risk of Postoperative Pain in the Comparison of Two National Reparative Cements for Full Pulpotomy in the Treatment of Irreversible Pulpitis in Primary Health Care: A Randomized Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-10z7snyp

Enrollment

120

Registered

2026-02-13

Start date

2025-11-11

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

This is a randomized controlled clinical trial with two parallel arms and a double-blind design, including a total of 120 participants, with 60 participants allocated to each study group. After clinic

however, participants and outcome assessors will be blinded to group allocation, characterizing a double-blind study. Complete pulpotomy procedures will be performed by multiple previously trained ope

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Systemically healthy patients; of both sexes; aged between 18 and 60 years; presenting permanent anterior or posterior teeth diagnosed with irreversible pulpitis associated with extremely deep caries (involvement of two-thirds or more of the dentin).

Exclusion criteria

Exclusion criteria: Teeth with a negative response to the vitality test; presence of edema; non-restorable crowns and immature roots; insufficient bleeding after pulp exposure suggestive of partial pulp necrosis; inability to control bleeding within 6 minutes; and a history of antibiotic intake within the previous month will also constitute exclusion criteria.

Design outcomes

Primary

Measure	Time frame
To evaluate the clinical and radiographic success rate of full pulpotomy in mature permanent teeth with a clinical diagnosis of irreversible pulpitis treated with different bioceramic cements. This outcome will be assessed through clinical and radiographic examinations performed at 3, 6, and 12 months of follow-up. The percentage of teeth exhibiting absence of clinical signs and symptoms of pulpal or periapical disease, absence of spontaneous or persistent pain, absence of tenderness to palpation and percussion, a healthy periodontium, and restoration integrity will be recorded, together with the absence of periapical radiolucency with a periapical index = 2, absence of root resorption, and presence of a hard tissue barrier. Results will be expressed as the percentage of success per group.	—

Measure

Time frame

To evaluate the clinical and radiographic success rate of full pulpotomy in mature permanent teeth with a clinical diagnosis of irreversible pulpitis treated with different bioceramic cements. This outcome will be assessed through clinical and radiographic examinations performed at 3, 6, and 12 months of follow-up. The percentage of teeth exhibiting absence of clinical signs and symptoms of pulpal or periapical disease, absence of spontaneous or persistent pain, absence of tenderness to palpation and percussion, a healthy periodontium, and restoration integrity will be recorded, together with the absence of periapical radiolucency with a periapical index = 2, absence of root resorption, and presence of a hard tissue barrier. Results will be expressed as the percentage of success per group.

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Secondary

Measure	Time frame
To evaluate the absolute risk of pain after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed through participants’ self-reported postoperative pain using the Visual Analog Scale (VAS). The percentage of participants reporting any value other than zero on the Visual Analog Scale during the follow-up period will be recorded, allowing estimation of the absolute risk of postoperative pain in each group.;To evaluate the intensity of postoperative pain after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed using a 100-mm Visual Analog Scale (VAS) for pain, applied before local anesthesia and postoperatively every 24 hours for seven days and again at 30 days. The highest score recorded on the Visual Analog Scale throughout the follow-up period will be considered, with pain categorized as none, mild, moderate, or severe according to the obtained values.;To evaluate the presence of bite sensitivity after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed by having the patient bite on an autoclaved latex device positioned in the region of the treated tooth. The presence or absence of pain elicited on biting will be recorded every 24 hours for seven days and again at 30 days, with results expressed as frequency and percentage per group.;To evaluate analgesic consumption in the postoperative period after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed through participants’ self-reported use of 400 mg ibuprofen among those who experience severe postoperative pain. The number of tablets ingested and the number of days of analgesic use during the follow-up period will be recorded, with data expressed as absolute values and mean values per group.;To evaluate the impact of the treatment on oral health–related quality of life after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed thr	—

Measure

Time frame

To evaluate the absolute risk of pain after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed through participants’ self-reported postoperative pain using the Visual Analog Scale (VAS). The percentage of participants reporting any value other than zero on the Visual Analog Scale during the follow-up period will be recorded, allowing estimation of the absolute risk of postoperative pain in each group.;To evaluate the intensity of postoperative pain after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed using a 100-mm Visual Analog Scale (VAS) for pain, applied before local anesthesia and postoperatively every 24 hours for seven days and again at 30 days. The highest score recorded on the Visual Analog Scale throughout the follow-up period will be considered, with pain categorized as none, mild, moderate, or severe according to the obtained values.;To evaluate the presence of bite sensitivity after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed by having the patient bite on an autoclaved latex device positioned in the region of the treated tooth. The presence or absence of pain elicited on biting will be recorded every 24 hours for seven days and again at 30 days, with results expressed as frequency and percentage per group.;To evaluate analgesic consumption in the postoperative period after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed through participants’ self-reported use of 400 mg ibuprofen among those who experience severe postoperative pain. The number of tablets ingested and the number of days of analgesic use during the follow-up period will be recorded, with data expressed as absolute values and mean values per group.;To evaluate the impact of the treatment on oral health–related quality of life after the pulpotomy procedure using different bioceramic cements. This outcome will be assessed thr

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Countries

Brazil

Contacts

Public ContactMaria Simões Silva

Centro Universitário do Maranhão - UniCEUMA

maria106597@ceuma.com.br+55 (98)991052081

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026