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Completed

NCT Number: NCT06322979

Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth

Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.

children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.

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Key information

Conditions

Periapical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • nonvital immature permanent teeth as a consequence of trauma or dental caries
  • nonvital permanent teeth with radiographic evidence of immature root end development
  • clinically restorable teeth

Exclusion criteria

  • immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
  • Immature nonvital permanent teeth associated with developmental abnormalities.
  • Patients with a history of systemically debilitating diseases
  • unrestorable remaining crown structure

Treatment and study plan

Mineral Trioxide Aggregate

Procedure

Apexification treatment was done with mineral trioxide aggregate

Premixed Bioceramic Putty

Procedure

Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)

Primary outcomes

  1. the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)

    Time frame: up to 12 months

    The apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.

  2. the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)

    Time frame: at 6 and12 months follow up

    The apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption.

    The apexification procedure will be radiographically unsuccessful if the apical lesion size increases.

    The apexification procedure will be doubtful if the apical lesion size doesn't change

Secondary outcomes

  1. Change in the periapical index (PAI)

    Time frame: at 6 and12 months follow up

    Radio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2024
Registry last updated
Apr 18, 2025

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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