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Completed

NCT Number: NCT04989036

Biodentine Vital Pulpotomy in Immature Molars

This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™). After a 12 months postoperative period, Biodentine ™ proved very useful as a successful pulpotomy agent in young permanent teeth.

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Key information

Conditions

Pulp Exposure, Dental Dental Pulp Diseases Dental Pulp Exposure Stomatognathic Diseases Tooth Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Objective: This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™).

Participants and methods:

This study was carried out on patients attending an outpatient clinic in Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry - Cairo University - Egypt. A total of thirty-five patients had thirty-eight vital immature first permanent molar with deep caries, who satisfied the eligibility criteria and completed the follow-up period. Their age ranged between six years to nine years old with a mean age of 7.5+/-1 years. All teeth were mandibular. In this study, pulpotomy was performed to preserve the vitality and function of the remaining radicular pulp tissue, followed by applying one of the investigated pulp capping materials.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical history: Healthy children with no physical or mental disorders assured through medical history questioning.
  • Mandibular vital immature first permanent molar with deep caries. Restorable. No clinical evidence of extensive pulp degeneration or periapical pathology.No radiographic evidence of periapical pathosis or interradicular bone loss, internal/external resorption and pulp calcification.

Exclusion criteria

  • 1. Patients refuse to cooperate. 2. Spontaneous pain or severe pain which doesn't stop with analgesics. 3. Hemorrhage control wasn't achievable at the operative procedures

Treatment and study plan

Pulpotomy

Procedure

Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed

Other names: vital pulp therapy, apexogensis

Primary outcomes

  1. Assessment of pain severity

    Time frame: 12 months

    ordinal outcome measured with direct questioning to the patient using Verbal Rating Scale ( VRS)

  2. Absences of swelling / fistulous tract

    Time frame: 12 months

    binary outcome observed clinically

Secondary outcomes

  1. Absence of tenderness to percussion

    Time frame: 12 months

    binary outcome detected by back of mirror

  2. Absence of internal or external root resorption

    Time frame: 12 months

    binary outcome detected in periapical radiograph

  3. Root maturation

    Time frame: 12 months

    binary outcome detected in periapical radiograph

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Apexogenesis Using Calcium Hydroxide Pulpotomy Versus Calcium Silicate-Based Material (Biodentine™) Pulpotomy in Cariously Exposed Vital Immature Permanent First Molars: A Randomized Controlled Trial With 12 Months Follow Up

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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