I. Materials:
Mineral trioxide aggregate (MTA)
Nano propolis
Nano curcumin
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.
