Clinical And Radiographic Evaluation Of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth

• ClinicalTrials.gov Identifier: NCT06029023
• Recruitment Status: Recruiting
• First Posted: September 8, 2023
• Last Update Posted: February 1, 2024
• Sponsor: Al-Azhar University
• Collaborator: October 6 University
• Information provided by (Responsible Party): Dalia Mohamed Elasser, Al-Azhar University

Tracking Information

• First Submitted Date: July 22, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: February 1, 2024
• Actual Study Start Date: January 20, 2023
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2023)

Incidence of pain or swelling [ Time Frame: 1 week ,3 month , 6 month ]

questionnaire applied for patient

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2023)

increase thickness of dentin bridge [ Time Frame: baseline ,6 month ]

digital cone beam radiograph

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical And Radiographic Evaluation Of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth
• Official Title: Clinical And Radiographic Evaluation of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth

Brief Summary

The aim of the study is to evaluate clinical and radiographic effect of nano propolis and nano curcumin as direct pulp capping agents in young permanent teeth.

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Detailed Description

I. Materials:

1. Mineral trioxide aggregate (MTA)
2. Nano propolis
3. Nano curcumin
4. Glass ionomer

II. Methods:

Sample size calculation:

Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a previous study. The predicted sample size (n) was (54), i.e., 18 samples per group of the three groups, to detect results of dentin bridge thickness.

Sample preparation:

Patients will be recruited from the department of Pediatric Dentistry and Dental Public Heath, October 6 university. The study sample will be recruited among the children between 7 to 13 years old. The young permanent tooth eruption stage will be determined by the patient's age and radiographic evaluation before enrolling in the research study.

Before treatment, a periapical radiograph will be taken with ultra-low dose mode to assess the tooth radiographically for any sign of irreversible pulpitis.

Each tooth will be infiltrated with local anesthesia using 4% articaine with 1:100,000 epinephrine (Septanest, Septodont, France). The tooth will be isolated with a rubber dam and washed with 0.12% chlorhexidine. The cavity will be prepared, and the infected enamel and dentin will be removed with a round bur. The carious dentin close to the pulp will be removed using a spoon excavator. The pulp exposure position will be identified, and the inflamed pulp tissue (1.5-2 mm) will be gently removed using an abrasive diamond bur at high speed with copious sterilized normal saline. The remaining healthy pulp will be rinsed with 2.5% sodium hypochlorite, and moist, sterilized cotton pellets will be placed over the pulp stumps with light pressure for 2 min to achieve hemostasis. If the bleeding could not be controlled, the tooth will be excluded from this study. MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturer's recommendation. To cover the exposure area, MTA and or nano propolis or nano curcumin will be placed using an amalgam carrier and non-toothed Adson forceps, respectively. The cavities will be lined with glass ionomer cement (Vitrebond, 3M ESPE, St. Paul, MN, USA), and a permanent composite restoration (Filtex Z350, 3M ESPE, Salt Lake City, UT, USA) will be placed after 6 months. After treatment, a periapical radiograph and CBCT (Planmeca. Romexis. Fenland) will be immediately taken with ultra-low dose mode (90 kVp, 5.6 mA, 4 × 5 cm FOV, and 0.2 vowel size) to serve as the baseline with a reduced dose, due to the need for future follow-ups.

The CBCT will be performed using an ultralow dose, small field of view, and appropriate radiation protection as described by the American Association of Endodontics (AAE) and the American Academy of Oral and Maxillofacial Radiology (AAOMR), and the European Society of Endodontology guidelines.

Shielding devices, a leaded thyroid collar, leaded glasses, and a leaded apron, will be used to protect the patient's thyroid gland, eye lens, body, respectively. The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment. Paracetamol will be prescribed if the patients had pain, however, no antibiotic will be used following the surgery. The patients will receive a 3-month follow-up clinical and periapical radiographic examination, together with 6 months clinical and CBCT examinations. The clinical and radiograph evaluations will be performed by blinded experienced endodontist and radiologist. The examiners will be trained in the evaluation criteria prior to the study. To determine the reliability of the evaluations, Kappa scores will be determined by the 2 examiners re-evaluating all cases 1 month after the initial evaluation performed. The intra- and inter-examiner Kappa scores of the clinical evaluation will be 1.0. For the radiographic evaluation, the intra-rater and inter-rater reliabilities will be 0.91 and 0.89, respectively. When there will be a disagreement, both examiners discussed the clinical and radiographic findings to achieve a consensus.

Variables:

Table 1: variables of the study:

Variables Referring to. Treatment agent MTA Nano propolis Nano curcumin

Time of assessment 6 months

Table 2: Interaction of variables of the study:

Variables Test MTA Nano propolis Nano curcumin Total Clinical examination 18 18 18 54 Dentin bridge formation. 18 18 18 54

Statistical Analysis:

All data will be collected, coded, tabulated and statistically analyzed.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Traumatic Pulp Exposure in Children

Intervention

Combination Product: MTA Cement, propolis nano particle, curcumin nanoparticles

MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturer's recommendation. The cavities will be lined with glass ionomer cement and a permanent composite restoration will be placed after 6 months. After treatment, a periapical radiograph and CBCT will be immediately taken with ultra-low dose The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment. Paracetamol will be prescribed if the patients had pain, however, no antibiotic will be used following the surgery. The patients will receive a 3-month follow-up clinical and periapical radiographic examination, together with 6 months clinical and CBCT examinations.

Study Arms

• Active Comparator: MTA
  Mineral trioxide aggregate MTA, The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.
  Intervention: Combination Product: MTA Cement, propolis nano particle, curcumin nanoparticles
• Experimental: Nano propolis
  Propolis is a resinous substance that honey bees collect from different plant species. The most important pharmacologically active constituents in propolis are flavonoids, phenolics, and aromatics.
  Intervention: Combination Product: MTA Cement, propolis nano particle, curcumin nanoparticles
• Experimental: Nano curcumin
  Curcumin (CUR), 7-bis (4-hydroxy-3-methoxyphenyl)-1,6- heptadien-3, 5-dione
  Intervention: Combination Product: MTA Cement, propolis nano particle, curcumin nanoparticles

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 6, 2023): 54
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Young permanent teeth with deep carious lesions that led to a caries-exposed pulp after spoon excavation and a diagnosis of reversible pulpitis.
• The tooth has a pulp exposure caused by trauma that occurred within 48 h.

Exclusion Criteria:

• The patient has a history of systemic disease that interferes with pulp healing.
• The tooth has clinical signs and symptoms of irreversible pulpitis, e.g., spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
• Radiographic evidence of internal or external resorption, inter-radicular bone loss, or periapical pathology.
• The tooth was non-restorable. During the study, if any symptoms of irreversible pulpitis, apical periodontitis, or infection occurred, the patients received the appropriate treatment following the institute protocol, including regenerative and root canal treatment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 13 Years (Child)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT06029023
• Other Study ID Numbers: october 6 university
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dalia Mohamed Elasser, Al-Azhar University
• Original Responsible Party: Same as current
• Current Study Sponsor: Al-Azhar University
• Original Study Sponsor: Same as current
• Collaborators: October 6 University
• Investigators: Not Provided
• PRS Account: Al-Azhar University
• Verification Date: January 2024