Vital Pulp Therapy With Different Materials for Young Permanent Teeth

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05498337

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will be conducted to:

Evaluate clinically and radiographically apexogenesis in immature permanent molars using:

Calcium Hydroxide.
MTA.
Laser.
Laser combined with MTA.

Condition or Disease	Intervention/Treatment	Phase
Vital Pulp Therapy	Other: calcium hydroxide Other: MTA Device: Diode Laser	N/A

Detailed Description

Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. It is the earliest medicament employed in pulpotomy that possesses the ability to stimulate tertiary dentinogenesis. This is attributed to its high alkalinity after mixing with water. Calcium hydroxide has a high pH, and its dental use relates chiefly to its ability to stimulate mineralization and also to its antibacterial property.

Biocompatibility and sealing ability are the most important properties, which account for optimal healing response in vital pulp therapy. Unlike conventional materials, MTA has low solubility and maintains its physical integrity after placement. It has several desirable characteristics in terms of biocompatibility, bioactivity, hydrophilicity, radiopacity, sealing ability and low solubility.

Diode laser in a young permanent tooth with traumatically exposed pulp has proved to be an effective technique for Pulpotomy in an immature tooth. Therefore, the use of soft-tissue diode lasers can influence the treatment outcome and should be seen as a predicable tool for vital pulp therapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Clinical Evaluation of Different Treatment Modalities for Vital Pulp of Immature Permanent Molars

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Examiner Examiner	Other: calcium hydroxide Dental pulp medicament material Other: MTA Dental pulp medicament material Device: Diode Laser Device used in pulp therapy
No Intervention: Patient Patient

Arm

Intervention/Treatment

Other: Examiner

Examiner

Other: calcium hydroxide

Dental pulp medicament material

Other: MTA

Dental pulp medicament material

Device: Diode Laser

Device used in pulp therapy

No Intervention: Patient

Patient

Outcome Measures

Primary Outcome Measures

Root completion [one year]
Closure of radiographic apex using Scanora 5.2.6 digital software

Secondary Outcome Measures

Root lengthening and thickening [one year]
Measuring the increase in length and width of the root canals using Scanora 5.2.6 digital software

Other Outcome Measures

Clinical evaluation [one year]
Absence of pain and tenderness to percussion using facial scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Medically free
Vital teeth

Exclusion Criteria:

Medically compromised
Chronic abscess
Non-vital teeth

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

Study Director: Salwa M Awad, Professor, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nada mohamed, Assistant lecturer, Mansoura University

ClinicalTrials.gov Identifier:

NCT05498337

Other Study ID Numbers:

Vital pulp therapy

First Posted:

Aug 12, 2022

Last Update Posted:

Aug 15, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nada mohamed, Assistant lecturer, Mansoura University

Additional relevant MeSH terms:

Calcium

Study Results

No Results Posted as of Aug 15, 2022