Bioceramic Sealer as an Obturation Material in Retained Primary Molars

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.

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Key information

Conditions

Pulpectomy Bioceramic Sealer

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Minia University Dental Hospital

Minya, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

bioceramic sealer

Biological

the root canals were obturated solely with Ceraseal bioceramic sealer

Other names: Ceraseal

Primary outcomes

number of participants with clinically successful treatment (Asymptomatic teeth)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Osama Seif El-Nasr Hussein Gad El-Hak

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 19, 2026
Registry last updated: Aug 20, 2026

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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Completed