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Completed

NCT Number: NCT04634123

The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.

- 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 .

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Key information

Conditions

Pulpotomies

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus Universite

Damascus, Syria

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulpotomy therapy by White Portland Cement

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

Pulpotomy therapy by White MTA

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.