Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA

NCT04650113 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: CARopacpIPMUM
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

that's comparison between partial and complete pulpotomy techniques in primary teeth

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (12)

• postoperative pain

  analog scale

  1 week

• postoperative pain

  analog scale

  1 month

• postoperative pain

  analog scale

  3 months

• postoperative pain

  analog scale

  6 months

• swelling

  clinical examination

  1 week

• swelling

  clinical examination

  1 month

• swelling

  clinical examination

  3 months

• swelling

  clinical examination

  6 months

• mobility

  clinical examination

  1 week

• mobility

  clinical examination

  1 month

• mobility

  clinical examination

  3 months

• mobility

  clinical examination

  6 months

Secondary Outcomes (8)

• root resorption

  1 week

• root resorption

  1 month

• root resorption

  3 months

• root resorption

  6 months

• Bone resorption

  1 week

Study Arms (2)

group A

EXPERIMENTAL

placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement

Combination Product: MTA material

group B

ACTIVE COMPARATOR

1. Pre-operative radiograph showing all roots and their apices. 2. Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth. 3. Removal of caries 4. Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant. 5. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece 6. Pulp amputation will perform using a spoon excavator. 7. Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 8. The pellet will be remove, and the pulp chamber will be filled with MTA. 9. The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement. The periapical radiographic will be taken at this baseline visit .

Combination Product: MTA material

Interventions

MTA material COMBINATION_PRODUCT

Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.

Also known as: partial pulpotomy procedure

group A; group B

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Medically free children who will be able and cooperative in all steps of the study.
• \- Asymptomatic primary molars with a deep carious lesion.
• \- Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
• Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
• Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.

You may not qualify if:

• Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
• Parent or guardians who refuse participating in the study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry cairo university

Al Manyal, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• adel El-bardissy, prof

  Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university

  STUDY DIRECTOR

• rasha ragab, phd

  Lecturer of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university

  STUDY DIRECTOR

Central Study Contacts

fatma abdelraouf, Msc

CONTACT

00201060771955; fatmaraouf.fr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will be randomly assigned to know which one of the right or left side will be allocated randomly in either the control or the intervention group. Sequence Generation Eligible consented participants will be randomly assigned to know which one of the participants will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized. The table of sequence generation will be kept with the co-supervisor.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 2, 2020
• Study Start: January 20, 2021
• Primary Completion: June 30, 2021
• Study Completion: September 3, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

EG (1)