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

NCT06322979 | Completed

• 1 other identifier: # R-PED-11-23-3074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periapical Periodontitis

Keywords

immature teeth; apexification; apical plug

Outcome Measures

Primary Outcomes (2)

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

  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.

  up to 12 months

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

  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

  at 6 and12 months follow up

Secondary Outcomes (1)

• Change in the periapical index (PAI)

  at 6 and12 months follow up

Study Arms (2)

MTA group

ACTIVE COMPARATOR

After the endodontic procedure, MTA will be placed into the apical 4 mm of the root canals. then a moist cotton pellet will be placed and the access cavity will be restored with GIC. Next day, GIC and the cotton pellet will be removed the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.

Procedure: Mineral trioxide aggregate

Premixed Bioceramic Putty group

EXPERIMENTAL

After the endodontic procedure, Premixed Bioceramic Putty (Well-Root™ PT) will be placed into the apical 4mm 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.

Procedure: Premixed Bioceramic Putty

Interventions

Mineral trioxide aggregate PROCEDURE

Apexification treatment was done with mineral trioxide aggregate

MTA group

Premixed Bioceramic Putty PROCEDURE

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

Premixed Bioceramic Putty group

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

Location

Related Publications (1)

• Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

  PMID: 3457698 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

mineral trioxide aggregate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric dentistry

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: November 22, 2023
• Primary Completion: November 12, 2024
• Study Completion: December 5, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)