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Bioceramic Sealer as an Obturation Material in Retained Primary Molars

Clinical and Radiographic Outcomes of Bioceramic Sealer as an Obturation Material in Primary Molars With Congenitally Missing Permanent Successors: A Prospective Single-Arm Feasibility Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07772986
Enrollment
30
Registered
2026-08-19
Start date
2023-03-15
Completion date
2026-06-24
Last updated
2026-08-20

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

Conditions

Bioceramic Sealer, Pulpectomy

Keywords

pulpectomy, retained primary molars

Brief summary

The goal of this single arm clinical trial was to to explore the clinical feasibility and radiographic outcome of the injectable bioceramic sealer as an obturation material for primary molars with congenitally missing permanent successors. The main question it aimed to answer was: Does injectable bioceramic sealers can be used as an obturation material for primary molars with congenitally missing permanent successors? Researchers used a commercially available bioceramic sealer as a sole obturation material for pulpectomized primary molars with congenitally missing permanent successors Eligible participants underwent pulpectomy treatment and followed up at 3,6,12 and 24 months postoperatively to evaluate clinical and radiographic success.

Interventions

the root canals were obturated solely with Ceraseal bioceramic sealer

Sponsors

Osama Seif El-Nasr Hussein Gad El-Hak
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Healthy (ASA I or II) children. * Cooperative (Frankel behavior rating 3 or 4) children * children having at least one mandibular primary 2nd molar with deep carious lesion. * No radiographic evidence of the developing permanent successor on orthopantomogram. * Signs and symptoms typical of irreversible pulpitis or pulp necrosis. * patients with minimal crowding (1-3 mm) or perfect alignment according to the Little's Irregularity Index in the lower arch.

Exclusion criteria

* Non-restorable primary molars. * Primary molars with severe infra-occlusion. * Presence of iatrogenic or pathological perforation of the pulpal floor. * Post-deroofing presence of healthy vital pulp, presenting as uniformly reddish pink vascular tissue. * Preoperative radiograph showing signs of internal or external pathological root resorption. * Root canal calcification.

Design outcomes

Primary

MeasureTime frameDescription
number of participants with clinically successful treatment (Asymptomatic teeth)3 months postoperatively, 6 months postoperatively, 12 months postoperatively, 24 months postoperatively.* The tooth is asymptomatic, with no pain or discomfort. * Absence of tenderness upon percussion or palpation. * No evidence of pathological tooth mobility, soft tissue swelling, sinus tract formation, or purulent discharge from the gingival margin.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026