Comparative evaluation of amniotic membrane with and without bioceramic material as pulpotomy agents

Quantification of active MMP9 and comparative evaluation of Biodentine with and without Human Amniotic Membrane as pulpotomy agents in mature permanent molars with symptomatic irreversible pulpitis A randomized controlled trial. - None

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/089910

Enrollment

Registered

2025-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

None listed

Interventions

Intervention1: Human amniotic membrane with Biodentine: Coronal Pulpotomy in mandibular molars using Human amniotic membrane with Biodentine as pulpotomy agents. Restoration with RMGIC and composite r

Eligibility

Inclusion criteria

Inclusion criteria: Clinical diagnosis of SIP without/with periapical rarefaction. (PAI score 1 to 3) The tooth should give positive response to cold testing. The tooth is restorable, probing pocket depth and mobility are within normal limits. No signs of pulpal necrosis including sinus tract or swelling. Mobility within normal limits. Radiographically, no evidence of pathological root resorption, and periapical or furcal radiolucency.

Exclusion criteria

Exclusion criteria: Teeth with immature roots Non restorable teeth Negative response to cold testing, the presence of sinus tract or swelling No pulp exposure after caries excavation Bleeding could not be controlled after full pulpotomy in 10 minutes Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic Systemic diseases like haemophilia, Von Willebrand disease, platelet abnormalities, and diabetes were excluded.

Design outcomes

Primary

Measure	Time frame
Patients will be asked to record their pain on a 100mm long visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be. An investigator blinded to the study group instructed all the participants. Timepoint: 24 and 48 hours	—

Secondary

Measure	Time frame
Clinically, teeth will be evaluated for presence or absence of signs and symptoms associated with any pulpal or periapical disease (spontaneous or persistent pain, discomfort, tenderness on palpation or percussion, sinus, swelling of surrounding tissue), cold and electric pulp testing, periodontal status and the integrity of the restoration. Radiographically, the assessment will be performed by two calibrated experienced endodontists independently for the evidence of any pathosis like periapical radiolucency (PAI upto 3), furcation involvement or internal/external root resorption. If any disagreement occurs, a consensus will be reached after a mutual discussion. Timepoint: 1, 3, 6 and 12 months	—

Measure

Time frame

Clinically, teeth will be evaluated for presence or absence of signs and symptoms associated with any pulpal or periapical disease (spontaneous or persistent pain, discomfort, tenderness on palpation or percussion, sinus, swelling of surrounding tissue), cold and electric pulp testing, periodontal status and the integrity of the restoration. Radiographically, the assessment will be performed by two calibrated experienced endodontists independently for the evidence of any pathosis like periapical radiolucency (PAI upto 3), furcation involvement or internal/external root resorption. If any disagreement occurs, a consensus will be reached after a mutual discussion. Timepoint: 1, 3, 6 and 12 months

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Countries

India

Contacts

Public ContactDr Marina Fernandes

Goa Dental College and Hospital

docrmarina@gmail.com9049666453

Outcome results