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

Periapical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322979
• Other study ID #: # R-PED-11-23-3074
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: shaimaa eldesouky, lecturer
• Phone: 01008994242
• Email: shaimaaeldesouky[@]dent.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Mineral trioxide aggregate
Apexification treatment was done with mineral trioxide aggregate
• Premixed Bioceramic Putty
Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

Tolibah YA, Kouchaji C, Lazkani T, Ahmad IA, Baghdadi ZD. Comparison of MTA versus Biodentine in Apexification Procedure for Nonvital Immature First Permanent Molars: A Randomized Clinical Trial. Children (Basel). 2022 Mar 14;9(3):410. doi: 10.3390/children9030410. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in the periapical index (PAI)	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-de?ned radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).	at 6 and12 months follow up