This study will be designed as a multi-arm randomized clinical trial Statement of the Problem Pulpotomy is the most commonly attempted pulp therapy procedure to treat pulp exposures in primary teeth; however, challenging pulp therapy can end up in failure and subsequent premature loss of primary teeth, which may bring about disturbances like ectopic eruption, alteration in eruption sequence, space loss, development of deleterious habits, functional and speech impairment.
Sample Size calculation If there is truly no difference between the standard treatments and Graphene oxide (99% in both groups), then 17 patients are required to be 80% sure that the two-sided 90% confidence interval will exclude a difference between the standard and experimental groups of more than 10%. This number is to be increased to 21 to compensate for losses during follow-up (20% more than the calculated). Sample size was calculated by Sealed Envelope Ltd. 2012. Power calculator for a binary outcome equivalence trial Statistical Methods Data will be analysed using IBM SPSS Advanced Statistics (Statistical Package for Social Sciences), Version 27.0. (Armonk, NY: IBM Corp) Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Data will be explored for normality using Kolmogrov Smirnov test and Shapiro Wilk test.
Comparisons between two groups for normally distributed numeric variables will be done using the Student's t test, while for non-normally distributed numeric variables will be done by Mann Whitney test. Comparisons between categorical variables will be performed using the chi-square test. An equivalence limit will be tested in comparison between groups. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two-tailed. Julious SA. Estimating Sample Sizes in Clinical Trials. CRC; 2009.
Study Setting and Population This study will involve children aged between 5 and 10 years old with primary teeth indicated for pulp therapy at the dental outpatient clinic of the Pediatric Dentistry and Dental Public Health Department of Al Azhar University, Cairo Boys.
Subject grouping:
The involved children (n=126) will be divided randomly into 2 arms; each arm has 3 groups, according to the type of pulp therapy dressing medicament and technique of its application, as follows:
First Arm (Vital Teeth) Group 1: will receive Graphene Oxide usingthe vital pulpotomy technique (study group, n=21) Group 2: will receive MTA using vital pulpotomy technique (study group, n=21) Group 3: will receive Zinc Oxide and Eugenol using the vital pulpotomy technique (control group, n=21) Second Arm (Non-Vital Teeth) Group A: will receive Graphene Oxide using the non-vital pulpotomy technique (study group, n=21).
Group B: will receive LSTR using the non-vital pulpotomy technique (study group, n=21).
Group C: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21).
Study Hypothesis The null hypothesis of the current study suggested that there will be no significant difference regarding the effect of Graphene Oxide (GO), Lesion sterilization and tissue repair (LSTR) and Zinc Oxide and Eugenol on the clinical and radiographic success rate of non-vital pulpotomy of primary teeth and that there will be no significant difference regarding the effect of Graphene Oxide (GO), MTA and Zinc Oxide and Eugenol on the clinical and radiographic success rate of vital pulpotomy of primary teeth.
PICO P: Children aged between 5 and 10 years old with primary teeth indicated for pulp therapy I: First arm (Vital): MTA, Graphene Oxide, and Zinc Oxide \& Eugenol Second arm (Non-Vital): LSTR, Graphene Oxide, and Zinc Oxide \& Eugenol C: Zinc Oxide and Eugenol O: Primary Outcome: Clinical and Radiographic Success Secondary Outcome: Presence or absence of pain, Patient satisfaction, and Time of procedure
Ethical Consideration:
This study will be carried out after approval of the Ethical Committee, Faculty of Dental Medicine (Boys, Cairo), Al-Azhar University, and the Ethical Committee of the General Organization for Teaching Hospitals and Institutes.
This clinical trial will be registered at ClinicalTrials.gov All children's parents/ guardians will be informed in a verbal manner about the aim of this research. In addition, a written informed consent will be signed by the parents/ guardians before starting the study Randomization and Allocation Concealment Participant children will also be randomized to the sequence of receiving the interventions using a computer-generated table of random numbers with allocation concealment, to receive either of the 4 management techniques Intervention Regarding the anesthesia, infiltration technique in the upper jaw and inferior alveolar nerve block in the lower arch were used, using one cartridge containing 0.2% lidocaine All pulpotomies will be performed by the same operator (first author) as a one-stage treatment First Arm (Vital Teeth) After administering local anesthesia, the tooth will be isolated with a rubber dam. All caries will be removed, and coronal access will be gained using a sterile No. 330 bur that will be mounted on a water-cooled high-speed turbine to expose the pulp chamber. A spoon excavator will be used for coronal pulp amputation. The pulp chamber will then be irrigated with saline solution to remove all debris. Hemostasis will be obtained with a moistened cotton pellet gently pressed against the amputated pulp stumps in both groups. Hemorrhage should stop within 5 min from the application of the cotton pellet. Pulpotomy material will be applied to cover the pulp chamber. MTA paste (ProRoot MTA, Dentsply, Tulsa, OK, USA) will be prepared as per the manufacturer's instructions to obtain a putty-like consistency. The mixture will be delivered to the pulp stumps and condensed lightly with a moistened sterile cotton pellet to ensure a thickness of 2 to 3 mm. A thick mix of zinc oxide eugenol (ZOE) cement base will be applied over the MTA.
The teeth of all tested groups will be restored after the pulp therapy using high-viscosity glass ionomer cement. After the removal of the rubber dam, SSCs will be cemented with glass ionomer cement. All procedures were done according to the manufacturer's specifications. Whenever necessary to adapt the SSC, the proximal surfaces of the primary molars will be reduced.
The time taken to perform the techniques will be recorded and counted starting after absolute isolation with a rubber dam and ending after restoration of the tooth with GIC, but before placement of the SSC.
After completion of the treatment procedures, immediate postoperative peri-apical radiographs will be taken using digital radiographs. The immediate postoperative radiograph will serve as a baseline record for the successive films. Images will be saved on a PC for further linear and density analysis, which was carried out using Digora image analysis software (Digora for Windows 2.5, Sordex Finndent, Finland).
The same radiographic records and measurements will be obtained twice at different times by the same examiner (second author), who was blind to the type of pulpotomy medicament used. The average readings will be recorded and used for comparisons between successive radiographs and for statistical analysis Children will be recalled after one week for clinical evaluation, then after three, six, nine, and twelve months, respectively, for clinical and radiographic evaluation Second Arm (Non-Vital Teeth) Absolute isolation with a rubber dam. Decayed dentin will be removed using spoon-shaped dentin excavators. The pulp chamber roof will be removed with a high-speed sterile carbide bur number 330, followed by irrigating the pulp chamber with two percent chlorhexidine solution and drying it with cotton balls.
After these steps, non-vital pulpotomy will be performed per the specific protocols indicated for each group.
The coronal parts will be restored by preformed stainless steel crowns. Outcomes Assessment Primary Outcome
1. Clinical success
The clinical evaluation criteria consisted of:
Assessing mobility, normal functioning, sensitivity to percussion, gingival inflammation, periodontal pocket formation, and presence or absence of sinus tract according to the scoring system Follow-Up Interval Immediate Postoperative, 1 week, 3 months, 6 months, and 12 months
2. Radiographic success
The radiographic evaluation criteria used were:
Radiographic evaluation will be assessed using DIGORA Software according to the scoring system Width of the periodontal membrane space in the furcation area (exactly at the middle of the furcation area and assessed in millimeters).
Presence or absence of internal root resorption /external root resorption. Radio-density of bone at the furcation area to assess the effect of the pulp therapy medicament on alveolar bone.
Follow-Up Interval (Immediate Postoperative, 3 months, 6 months, and 12 months) Secondary Outcome Presence or absence of pain Each child was asked to grade present pain on the Wong-Baker FACES Pain Rating Scale (WBFPS). Providing an evaluation of pain intensity at the moment of the patient interview Patient satisfaction Will be assessed by a 5-question Likert instrument assessment of satisfaction Time of procedure: A calibrated stopwatch will be used to record the time of the procedure
