The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.
November 26, 2021 updated by: Damascus University
Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth
- 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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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 :
- Absence of spontaneous or stimulant pain
- Absence gingival redness , swelling or fistula
- Physiological tooth mobility and absence sensitivity to percussion
Radiographically success criteria :
- Absence periapical translucence
- Absence external or internal abnormal absorption
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Damascus, Syrian Arab Republic
- Damascus Universite
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 9 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 4 and 9 years.
- Definitely positive or positive ratings of Frank scale.
- Caries include maximum two surfaces
- Pulp exposure during caries removal
- Pulpal hemorrhage light red acceptable to hemostasis
- Physiological root resorption no more than the apical third
- Absence clinical and radiographic signs which indicate pulp necrosis
Exclusion Criteria:
- Systematic or mental disorders.
- Definitely negative or negative ratings of Frankel scale
- Existence periapical translucence
- Existence external or internal abnormal absorption
- Existence swelling or fistula
- Sensitivity to percussion
- Existence of spontaneous or stimulant pain
- Excessive movement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Primary anterior teeth pulpotomy 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
|
|
OTHER: Primary anterior teeth pulpotomy by White MTA
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment
Time Frame: 3 months
|
Clinical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset clinical criteria.
The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
|
3 months
|
|
Clinical evaluation of White Portland Cement pulpotomies 6 months after treatment
Time Frame: 6 months
|
Clinical evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using the preset clinical criteria.
The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
|
6 months
|
|
Clinical evaluation of White Portland Cement pulpotomies 12 months after treatment
Time Frame: 12 months
|
Clinical evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using the preset clinical criteria.
The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
|
12 months
|
|
Clinical evaluation of White MTA pulpotomies 3 months after treatment
Time Frame: 3 months
|
Clinical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset clinical criteria.
The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
|
3 months
|
|
Clinical evaluation of White MTA pulpotomies 6 months after treatment
Time Frame: 6 months
|
Clinical evaluation of White MTA pulpotomies was performed 6 months after treatment using the preset clinical criteria.
The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
|
6 months
|
|
Clinical evaluation of White MTA pulpotomies 12 months after treatment
Time Frame: 12 months
|
Clinical evaluation of White MTA pulpotomies was performed 12 months after treatment using the preset clinical criteria.
The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
|
12 months
|
|
Radiographic evaluation of White Portland Cement pulpotomies 3 months after treatment
Time Frame: 3 months
|
Radiographic evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using periapical radiographs.
The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption.
If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
|
3 months
|
|
Radiographic evaluation of White Portland Cement pulpotomies 6 months after treatment
Time Frame: 6 months
|
Radiographic evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using periapical radiographs.
The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption.
If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
|
6 months
|
|
Radiographic evaluation of White Portland Cement pulpotomies 12 months after treatment
Time Frame: 12 months
|
Radiographic evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using periapical radiographs.
The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption.
If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
|
12 months
|
|
Radiographic evaluation of White MTA pulpotomies 3 months after treatment
Time Frame: 3 months
|
Radiographic evaluation of White MTAt pulpotomies was performed 3 months after treatment using periapical radiographs.
The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption.
If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
|
3 months
|
|
Radiographic evaluation of White MTA pulpotomies 6 months after treatment
Time Frame: 6 months
|
Radiographic evaluation of White MTAt pulpotomies was performed 6 months after treatment using periapical radiographs.
The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption.
If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
|
6 months
|
|
Radiographic evaluation of White MTA pulpotomies 12 months after treatment
Time Frame: 12 months
|
Radiographic evaluation of White MTAt pulpotomies was performed 12 months after treatment using periapical radiographs.
The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption.
If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
|
12 months
|
|
Histopathlogic evaluation of White Portland Cement 3 months after treatment
Time Frame: 3 months
|
Histopathlogical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria.
The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification
|
3 months
|
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Histopathlogic evaluation of White MTA 3 months after treatment
Time Frame: 3 months
|
Histopathlogical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria.
The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hasan M Alzoubi, DDs, MSc student in Pedodontics, University of Damascus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2020
Primary Completion (ACTUAL)
November 30, 2020
Study Completion (ACTUAL)
July 1, 2021
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
November 15, 2020
First Posted (ACTUAL)
November 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 9, 2021
Last Update Submitted That Met QC Criteria
November 26, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- UDDS-Pedo-02-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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