The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.

NCT ID: NCT04634123

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-07-01

Brief Summary

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\- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in primary anterior teeth pulpotomy and follow up after 3 , 6 , 12 months ( Clinically and Radiographically) : Group A ( Control group ) : primary anterior teeth pulpotomized by White MTA . Group B : primary anterior teeth pulpotomized by White Portland Cement .

\- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in pulpotomy primary canines for serial extraction and extract them after 3 months for Histopathlogic study : Group A ( Control group ) : primary canines pulpotomized by White MTA . Group B : primary canines pulpotomized by White Portland Cement .

Detailed Description

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* Endodontic therapy for primary teeth faces several difficulties including morphology of root canals , physiological root absorption and failure to find ideal root-filling paste absorbs the same degree of root absorption .
* Pulpotomy therapy is considered easy , fast and does not include the length of canal or periapical region .
* The split mouth design will be adopted for the treated samples .
* Clinical success criteria :

1. Absence of spontaneous or stimulant pain
2. Absence gingival redness , swelling or fistula
3. Physiological tooth mobility and absence sensitivity to percussion
* Radiographically success criteria :

1. Absence periapical translucence
2. Absence external or internal abnormal absorption

Conditions

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Pulpotomies

Keywords

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Pulpotomy Portland cement Primary Anterior Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Split mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Primary anterior teeth pulpotomy by White Portland Cement

Group Type EXPERIMENTAL

Pulpotomy therapy by White Portland Cement

Intervention Type OTHER

Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined using a sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White Portland Cement

Primary anterior teeth pulpotomy by White MTA

Group Type OTHER

Pulpotomy therapy by White MTA

Intervention Type OTHER

Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined usinga sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White MTA

Interventions

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Pulpotomy therapy by White Portland Cement

Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined using a sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White Portland Cement

Intervention Type OTHER

Pulpotomy therapy by White MTA

Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined usinga sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White MTA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age between 4 and 9 years.
2. Definitely positive or positive ratings of Frank scale.
3. Caries include maximum two surfaces
4. Pulp exposure during caries removal
5. Pulpal hemorrhage light red acceptable to hemostasis
6. Physiological root resorption no more than the apical third
7. Absence clinical and radiographic signs which indicate pulp necrosis

Exclusion Criteria

1. Systematic or mental disorders.
2. Definitely negative or negative ratings of Frankel scale
3. Existence periapical translucence
4. Existence external or internal abnormal absorption
5. Existence swelling or fistula
6. Sensitivity to percussion
7. Existence of spontaneous or stimulant pain
8. Excessive movement
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hasan M Alzoubi, DDs

Role: PRINCIPAL_INVESTIGATOR

MSc student in Pedodontics, University of Damascus

Nada G Bshara, Phd

Role: STUDY_DIRECTOR

Professor of Pedodontics, Department of Pedodontics, University of Damascus

Locations

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Damascus Universite

Damascus, , Syria

Site Status

Countries

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Syria

References

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Nguyen TD, Judd PL, Barrett EJ, Sidhu N, Casas MJ. Comparison of Ferric Sulfate Combined Mineral Trioxide Aggregate Pulpotomy and Zinc Oxide Eugenol Pulpectomy of Primary Maxillary Incisors: An 18-month Randomized, Controlled Trial. Pediatr Dent. 2017 Jan 15;39(1):34-38.

Reference Type BACKGROUND
PMID: 28292339 (View on PubMed)

Aminabadi NA, Farahani RM, Gajan EB. A clinical study of formocresol pulpotomy versus root canal therapy of vital primary incisors. J Clin Pediatr Dent. 2008 Spring;32(3):211-4. doi: 10.17796/jcpd.32.3.ghk26v4554790074.

Reference Type BACKGROUND
PMID: 18524271 (View on PubMed)

Casas MJ, Kenny DJ, Johnston DH, Judd PL, Layug MA. Outcomes of vital primary incisor ferric sulfate pulpotomy and root canal therapy. J Can Dent Assoc. 2004 Jan;70(1):34-8.

Reference Type BACKGROUND
PMID: 14709254 (View on PubMed)

Howley B, Seale NS, McWhorter AG, Kerins C, Boozer KB, Lindsey D. Pulpotomy versus pulpectomy for carious vital primary incisors: randomized controlled trial. Pediatr Dent. 2012 Sep-Oct;34(5):112-9.

Reference Type BACKGROUND
PMID: 23211895 (View on PubMed)

Islam I, Chng HK, Yap AU. Comparison of the root-end sealing ability of MTA and Portland cement. Aust Endod J. 2005 Aug;31(2):59-62. doi: 10.1111/j.1747-4477.2005.tb00223.x.

Reference Type BACKGROUND
PMID: 16128253 (View on PubMed)

Other Identifiers

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UDDS-Pedo-02-2021

Identifier Type: -

Identifier Source: org_study_id