Effect of Graphene Oxide on Vital and Non-Vital Primary Teeth Compared to the Conventional Techniques
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorAl-Azhar University
About this trial
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.
The children (n=126) will be divided randomly into 2 arms; each arm has 3 groups, according to the type of pulp therapy dressing, medicament,t and technique of its application as follows:
First Arm (Vital Teeth) Group 1: will receive Graphene Oxide using the 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).
Clinical and radiographic success will be assessed as primary outcomes, while pain, patient satisfaction,n and time of procedure will be assessed as secondary outcomes.
Eligibility criteria
Qualifiers
Cooperative child
Presence of symptom-free deep carious lesions
Presence of at least two-thirds of the root length radiographically; restorable tooth
Primary teeth diagnosed with pulp necrosis, root resorption equal to or less than one-third (with sufficient dental structure for absolute isolation with rubber dam)
Disqualifiers
History of systemic diseases
Teeth showing clinical and radiographical evidence of pulp degeneration, such as history of spontaneous or nocturnal pain, tenderness to percussion or palpation, pathologic mobility, swelling or fistulous tract, periodontal ligament (PDL) space widening, internal root resorption, external root resorption, furcal radiolucency/inter-radicular bone destruction, and/or periapical bone destruction
Teeth without a permanent successor
Teeth requiring more than 5 minutes to achieve hemostasis during the clinical procedure
Trial design
Treatments tested in this trial
- Graphene Oxide using vital pulpotomy technique
- MTA using vital pulpotomy technique
- Zinc Oxide and Eugenol using vital pulpotomy technique
- Graphene Oxide using non-vital pulpotomy technique
- LSTR using non-vital pulpotomy technique
- Zinc Oxide and Eugenol using non-vital pulpotomy
Treatment groups
126 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov