Pulpotomies Clinical Trial
Official title:
Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth
| Verified date | November 2021 |
| Source | Damascus University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
- 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 .
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | July 1, 2021 |
| Est. primary completion date | November 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 9 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Syrian Arab Republic | Damascus Universite | Damascus |
| Lead Sponsor | Collaborator |
|---|---|
| Damascus University |
Syrian Arab Republic,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 3 months | |
| Primary | 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 | 6 months | |
| Primary | 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 | 12 months | |
| Primary | 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 | 3 months | |
| Primary | 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 | 6 months | |
| Primary | 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 | 12 months | |
| Primary | 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 | 3 months | |
| Primary | 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 | 6 months | |
| Primary | 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 | 12 months | |
| Primary | 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 | 3 months | |
| Primary | 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 | 6 months | |
| Primary | 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 | 12 months | |
| Primary | 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 | 3 months | |
| Primary | 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 | 3 months |