Success rates of three different root canal filling materials in primary molars

Phase 2

Not yet recruiting

• Conditions: Primary molars with caries involving pulp

• Registration Number: CTRI/2025/05/087046
• Lead Sponsor: Dr Muppa Susmitha

Brief Summary

Preservation of primary teeth is essential as they guide the permanent teeth, maintaining arch length and function. Endodontic treatment, specifically pulpectomy, is crucial for primary teeth with infected and necrotic pulp. Chemomechanical therapy alone often fails to disinfect all bacteria, necessitating a filling paste that is antibacterial, biocompatible, radiopaque, adheres to canal walls without voids, resorbable if it goes beyond the apex, easily removable when needed.  

AIM OF THE STUDY The aim of the study is to evaluate the clinical and radiographic success rate of a mixture of Zinc oxide-nanohydroxyapatite powder with aloevera gel, Metapex, and Endoflas as obturating material in primary molars.

OBJECTIVES OF THE STUDY

1)To clinically and radiographically evaluate the success rate of a mixture of Zinc oxide-nanohydroxyapatite powder with aloevera gel as an obturating material in primary molars.

2)To clinically and radiographically evaluate the success rate of Metapex as obturating material in primary molars.

3)To clinically and radiographically evaluate the success rate of Endoflas as obturating material in primary molars.

4)To compare clinical and radiographic success rates of a mixture of Zinc oxide nanohydroxyapatite powder with alovera gel, Metapex, and Endoflas as obturating material in primary molars.

Group I– Metapex. Group II – Endoflas. Group III– Mixture of zinc oxide-nano hydroxyapatite powder with aloevera gel.

Post endodontic restoration with type - II Glass ionomer cement will be done followed by the placement of semi-permanent crowns after 1 month. Clinical evaluation will be done for pain, tenderness on percussion, gingival swelling or inflammation, mobility, presence of fistula or sinus opening. A postoperative digital radiograph will be taken for assessment of the obturation quality and will be categorized as underfilled, optimal filled, or overfilled canals, furcation or periapical radiolucency, extensive pathological root resorption. Both clinical and radiographic evaluation of the pulpectomy treated teeth will be carried out at 3, 6, and 9 months respectively.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-15
• Study Start: 2025-07-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

History of spontaneous pain Primary molars with caries involving the pulp Presence of atleast 2/3rd of root length Presence of inter/periapical radiolucency Tooth that cannot be restorable.

Exclusion Criteria

Children with any underlying systemic diseases Preshedding and abnormal pathologic mobility Any sinus opening or fistula In case of internal or external resorption Extensive inter/periapical radiolucency Tooth that cannot be restorable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars.	To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months
To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars.	To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months
To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars.	To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months
To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars.	To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months

Trial Locations

Locations (1)

Kamineni institute of dental sciences; 🇮🇳 Nalgonda, TELANGANA, India

Kamineni institute of dental sciences

🇮🇳Nalgonda, TELANGANA, India

Dr Muppa Susmitha

Principal investigator

7995741589

susmithareddymuppa@gmail.com