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CompletedNCT04634123Updated Dec 9, 2021

The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.

An interventional study of Pulpotomy therapy by White Portland Cement and Pulpotomy therapy by White MTA in Pulpotomies, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2021-12-09.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study summary

  • 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 .
Read the 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 :

    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
02

Conditions studied

  • Pulpotomies

Keywords

  • Pulpotomy
  • Portland cement
  • Primary Anterior Teeth
03

In context

Lead sponsor

Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Primary anterior teeth pulpotomy by White Portland Cement

    Other: Pulpotomy therapy by White Portland Cement

  • Other
    Primary anterior teeth pulpotomy by White MTA

    Other: Pulpotomy therapy by White MTA

Interventions

  • OtherPulpotomy 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

  • OtherPulpotomy 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

06

What researchers measure

Primary outcomes

  1. Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment

    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

    Time frame: 3 months

  2. Clinical evaluation of White Portland Cement pulpotomies 6 months after treatment

    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

    Time frame: 6 months

  3. Clinical evaluation of White Portland Cement pulpotomies 12 months after treatment

    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

    Time frame: 12 months

  4. Clinical evaluation of White MTA pulpotomies 3 months after treatment

    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

    Time frame: 3 months

  5. Clinical evaluation of White MTA pulpotomies 6 months after treatment

    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

    Time frame: 6 months

  6. Clinical evaluation of White MTA pulpotomies 12 months after treatment

    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

    Time frame: 12 months

  7. Radiographic evaluation of White Portland Cement pulpotomies 3 months after treatment

    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

    Time frame: 3 months

  8. Radiographic evaluation of White Portland Cement pulpotomies 6 months after treatment

    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

    Time frame: 6 months

  9. Radiographic evaluation of White Portland Cement pulpotomies 12 months after treatment

    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

    Time frame: 12 months

  10. Radiographic evaluation of White MTA pulpotomies 3 months after treatment

    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

    Time frame: 3 months

  11. Radiographic evaluation of White MTA pulpotomies 6 months after treatment

    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

    Time frame: 6 months

  12. Radiographic evaluation of White MTA pulpotomies 12 months after treatment

    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

    Time frame: 12 months

  13. Histopathlogic evaluation of White Portland Cement 3 months after treatment

    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

    Time frame: 3 months

  14. Histopathlogic evaluation of White MTA 3 months after treatment

    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

    Time frame: 3 months

07

Study locations

1 site
  • Damascus Universite
    Damascus, Syrian Arab Republic
08

References and documents

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. PubMed 28292339 ↗
  • 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. PubMed 18524271 ↗
  • 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. PubMed 14709254 ↗
  • 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. PubMed 23211895 ↗
  • 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. PubMed 16128253 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04634123
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Nov 18, 2020
Start date
Apr 1, 2020
Primary completion
Nov 30, 2020
Completion
Jul 1, 2021
Last update
Dec 9, 2021

Study contacts

Hasan M Alzoubi, DDs
principal investigator · MSc student in Pedodontics, University of Damascus
Nada G Bshara, Phd
study director · Professor of Pedodontics, Department of Pedodontics, University of Damascus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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