Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA

Phase 1

• Conditions: Pulp Disease, Dental
• Interventions: Combination Product: MTA material

• Registration Number: NCT04650113
• Lead Sponsor: Cairo University

Brief Summary

that's comparison between partial and complete pulpotomy techniques in primary teeth

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-11-24
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02
• Study Start: 2021-01-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. • Medically free children who will be able and cooperative in all steps of the study.
2. • Asymptomatic primary molars with a deep carious lesion.
3. • Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.

3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.

4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.

Exclusion Criteria

1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.

6 - Parent or guardians who refuse participating in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group A	MTA material	placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement
group B	MTA material	1. Pre-operative radiograph showing all roots and their apices. 2. Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth. 3. Removal of caries 4. Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant. 5. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece 6. Pulp amputation will perform using a spoon excavator. 7. Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 8. The pellet will be remove, and the pulp chamber will be filled with MTA. 9. The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement. The periapical radiographic will be taken at this baseline visit .

Primary Outcome Measures

Name	Time	Method
swelling	6 months	clinical examination
postoperative pain	6 months	analog scale
mobility	6 months	clinical examination

Secondary Outcome Measures

Name	Time	Method
root resorption	6 months	periapical radiograph
Bone resorption	6 months	periapical radiograph

Trial Locations

Locations (1)

Faculty of dentistry cairo university; 🇪🇬 Al Manyal, Cairo, Egypt