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

NCT07424053 | Not Yet Recruiting

• 1 other identifier: 1198/6144
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Primary Teeth Indicated for Pulp Therapy

Keywords

LSTR; MTA; Zinc Oxide and Eugenol; Graphene Oxide; Vital pulpotomy; Non Vital Pulpotomy; Primary teeth; Conventional Pulp therapy techniques

Outcome Measures

Primary Outcomes (2)

• Clinical success

  Assessing mobility, normal functioning, sensitivity to percussion, gingival inflammation, periodontal pocket formation, and presence or absence of sinus tract according to a scoring system from (1) to (4) as follows: Score (1): Asymptomatic Pathology: absent Normal functioning Mobility: (physiological) ≤ 1mm Score (2): Slight Discomfort, short-lived Pathology: questionable Percussion sensitivity Gingival inflammation: (due to poor oral hygiene) Mobility: (physiological) ≤ 1mm Score (3): Minor discomfort, short-lived Pathology: initial changes present Gingival swelling: (not due to poor oral hygiene) Mobility: \> 2 mm but \< 3 mm Score (4): Major discomfort, long-lived. Extract immediately Pathology: Late changes present Spontaneous pain Gingival swelling: (not due to poor oral hygiene) Periodontal pocket formation (exudate) Sinus tract present Mobility: ≤ 3mm Premature tooth loss due to pathology

  Immediate Postoperative, 1 week, 3 months, 6 months and 12 months

• Radiographic success

  Radiographic evaluation will be assessed using a scoring system from score (1) to (4) as follows: Score (1): No changes at 6 months follow-up\* Internal root canal tapering from the chamber to the apex Periodontal ligament \\ periapical regions; normal width and trabeculation Score (2): Questionable Pathological changes at 3 months follow-up\* No External changes (widened PDL), abnormal inter-radicular trabeculation, or variation in radiodensity Internal resorption is acceptable (not perforated) Calcific metamorphosis is acceptable Score (3): Pathological changes present at 1-month follow-up\* External changes are present, but not large Mildly widened PDL Minor inter-radicular radiolucency with trabeculation still present Minor external root resorption; internal resorption changes are acceptable, but not if external changes are also present (perforated form) Score (4): Pathological changes are present. Extract immediately Frank osseous radiolucency present

  Immediate Postoperative, 3 months, 6 months and 12 months

Secondary Outcomes (3)

• Presence or absence of pain

  Immediate Postoperative

• Patient satisfaction

  Immediate Postoperative

• Time of procedure

  Immediate Postopertive

Study Arms (6)

Group 1: will receive Graphene Oxide using vital pulpotomy technique

EXPERIMENTAL

Group 1: Vital Teeth will receive Graphene Oxide using vital pulpotomy technique (study group, n=21)

Other: Graphene Oxide using vital pulpotomy technique

Group 2: MTA using vital pulpotomy technique

EXPERIMENTAL

Group 2: will receive MTA using vital pulpotomy technique (study group, n=21)

Other: MTA using vital pulpotomy technique

Group 3: will receive Zinc Oxide and Eugenol using vital pulpotomy technique (control group, n=21)

ACTIVE COMPARATOR

Group 3: will receive Zinc Oxide and Eugenol using vital pulpotomy technique (control group, n=21)

Other: Zinc Oxide and Eugenol using vital pulpotomy technique

Group a: will receive Graphene Oxide using non-vital pulpotomy technique (study group, n=21).

EXPERIMENTAL

Group a: will receive Graphene Oxide using non-vital pulpotomy technique (study group, n=21).

Other: Graphene Oxide using non-vital pulpotomy technique

Group b: will receive LSTR using non-vital pulpotomy technique (study group, n=21).

EXPERIMENTAL

Group b: will receive LSTR using non-vital pulpotomy technique (study group, n=21).

Other: LSTR using non-vital pulpotomy technique

Group c: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21)

ACTIVE COMPARATOR

Group c: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21).

Other: Zinc Oxide and Eugenol using non-vital pulpotomy

Interventions

Graphene Oxide using vital pulpotomy technique OTHER

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

Group 1: will receive Graphene Oxide using vital pulpotomy technique

MTA using vital pulpotomy technique OTHER

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

Group 2: MTA using vital pulpotomy technique

Zinc Oxide and Eugenol using vital pulpotomy technique OTHER

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

Group 3: will receive Zinc Oxide and Eugenol using vital pulpotomy technique (control group, n=21)

Graphene Oxide using non-vital pulpotomy technique OTHER

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.

Group a: will receive Graphene Oxide using non-vital pulpotomy technique (study group, n=21).

LSTR using non-vital pulpotomy technique OTHER

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.

Group b: will receive LSTR using non-vital pulpotomy technique (study group, n=21).

Zinc Oxide and Eugenol using non-vital pulpotomy OTHER

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.

Group c: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21)

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative child
• Presence of symptom-free deep carious lesions
• Presence of at least two-thirds of the root length radiographically; restorable tooth
• (Second Arm)
• 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)
• History of spontaneous pain and mobility incompatible with chronological age, possibly with the presence of a sinus tract or swelling
• Presence or absence of a radiolucent area in the periapical or furcation region

You may not qualify if:

• 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
• (Second Arm)
• Children with a history of allergic reaction to the components of the tested materials
• Children had used antibiotics in the last three months.
• Teeth with pulp canal obliteration or internal or external pathological root resorption visible in periapical radiographs
• Coronal destruction that would prevent absolute isolation with a rubber dam and/or restoration

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Interventions

Zinc Oxide

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Central Study Contacts

Mennah Helal, Master of science

CONTACT

00201009230087; mennah.helal2020@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Candidate, Pediatric Dentistry Department, Azhar University

Model Details: This study will involve children aged between 5 and 10 years old with primary teeth indicated for pulp therapy 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 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).

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02