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.