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NOT YET RECRUITING
NCT07424053
NA

Effect of Graphene Oxide on Vital and Non-Vital Primary Teeth Compared to the Conventional Techniques

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Graphene Oxide on Vital and Non-Vital Primary Teeth Compared to the Conventional Techniques: Randomized Multi-Arm Clinical Trial

Key Details

Gender

All

Age Range

5 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2026-04

Completion Date

2026-12-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

OTHER

Graphene Oxide using vital pulpotomy technique

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 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 of applying the cotton pellet. Graphene Oxide will be applied to cover the pulp chamber. 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. A thick mix of the material will be applied Teeth of all tested groups will be restored after the pulp therapy using high-viscosity glass ionomer

OTHER

MTA using vital pulpotomy technique

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 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 of applying the cotton pellet. MTA will be applied to cover the pulp chamber. 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. A thick mix of the material will be applied Teeth of all tested groups will be restored after the pulp therapy using high-viscosity glass ionomer

OTHER

Zinc Oxide and Eugenol using vital pulpotomy technique

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 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 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 of applying the cotton pellet. Zinc oxide Eugenol will be applied to cover the pulp chamber. 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. A thick mix of the material will be applied Teeth of all tested groups will be restored after the pulp therapy using high-viscosity glass ionomer

OTHER

Graphene Oxide using non-vital pulpotomy technique

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, a non-vital pulpotomy will be performed The coronal parts will be restored by preformed stainless steel crowns.

OTHER

LSTR using non-vital pulpotomy technique

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, a non-vital pulpotomy will be performed The coronal parts will be restored by preformed stainless steel crowns.

OTHER

Zinc Oxide and Eugenol using non-vital pulpotomy

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, a non-vital pulpotomy will be performed The coronal parts will be restored by preformed stainless steel crowns.