Clinical trial NCT04634123: The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.
Official title: Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpotomies
Keywords: Pulpotomy
Portland cement
Primary Anterior Teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split mouth design
Primary purpose: TREATMENT

Brief 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 .

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment
timeFrame: 3 months
measure: Clinical evaluation of White Portland Cement pulpotomies 6 months after treatment
timeFrame: 6 months
measure: Clinical evaluation of White Portland Cement pulpotomies 12 months after treatment
timeFrame: 12 months
measure: Clinical evaluation of White MTA pulpotomies 3 months after treatment
timeFrame: 3 months
measure: Clinical evaluation of White MTA pulpotomies 6 months after treatment
timeFrame: 6 months
measure: Clinical evaluation of White MTA pulpotomies 12 months after treatment
timeFrame: 12 months
measure: Radiographic evaluation of White Portland Cement pulpotomies 3 months after treatment
timeFrame: 3 months
measure: Radiographic evaluation of White Portland Cement pulpotomies 6 months after treatment
timeFrame: 6 months
measure: Radiographic evaluation of White Portland Cement pulpotomies 12 months after treatment
timeFrame: 12 months
measure: Radiographic evaluation of White MTA pulpotomies 3 months after treatment
timeFrame: 3 months
measure: Radiographic evaluation of White MTA pulpotomies 6 months after treatment
timeFrame: 6 months
measure: Radiographic evaluation of White MTA pulpotomies 12 months after treatment
timeFrame: 12 months
measure: Histopathlogic evaluation of White Portland Cement 3 months after treatment
timeFrame: 3 months
measure: Histopathlogic evaluation of White MTA 3 months after treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus Universite
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Hasan M Alzoubi, DDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Nada G Bshara, Phd
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.