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

ConditionPrimary Teeth Indicated for Pulp Therapy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Graphene Oxide using vital pulpotomy technique

    Other intervention

    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

  • MTA using vital pulpotomy technique

    Other intervention

    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

  • Zinc Oxide and Eugenol using vital pulpotomy technique

    Other intervention

    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

  • Graphene Oxide using non-vital pulpotomy technique

    Other intervention

    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.

  • LSTR using non-vital pulpotomy technique

    Other intervention

    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.

  • Zinc Oxide and Eugenol using non-vital pulpotomy

    Other intervention

    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.

Treatment groups

126 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group 1: will receive Graphene Oxide using vital pulpotomy techniqueExperimental treatment 1 intervention
Group B: Group 2: MTA using vital pulpotomy techniqueExperimental treatment 1 intervention
Group C: Group 3: will receive Zinc Oxide and Eugenol using vital pulpotomy technique (control group, n=21)Active comparator 1 intervention
Group D: Group a: will receive Graphene Oxide using non-vital pulpotomy technique (study group, n=21).Experimental treatment 1 intervention
Group E: Group b: will receive LSTR using non-vital pulpotomy technique (study group, n=21).Experimental treatment 1 intervention
Group F: Group c: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Immediate Postoperative, 1 week, 3 months, 6 months and 12 months
2

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

Time frame
Immediate Postoperative, 3 months, 6 months and 12 months

Secondary outcomes

1

Presence or absence of pain

Each child will be asked to grade present pain on Wong-Baker faces pain rating scale (WBFPS). Providing an evaluation of pain intensity at the moment of interview of patient. These scales were present sequentially. Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing degree of pain from left to right. Each face was attributed scale from 0 to 10 indicated on scale. Children will be asked to choose the face that best describes his or her own pain. Children will taught that each face is for a child who has no pain or some, or a lot. Face 0 does not hurt at all, Face 2 hurts just a little bit, Face 4 hurts a little more, Face 6 hurts even more, Face 8 hurts a whole lot, and Face 10 hurts as much as you can imagine

Time frame
Immediate Postoperative
2

Patient satisfaction

Will be assessed by 5-question Likert instrument assessment of satisfaction, patients will be asked to assess a number of statements in the five-point a novel Likert scale instrument, which includes five statements and five standard responses to them. Each of five statements was rated on a 5-point attitude scale of agreement-disagreement with treatment: Strongly disagree (1 score), Disagree (2 scores), Neither agree nor disagree (3 scores), Agree (4 scores), and Strongly-agree (5 scores).

Time frame
Immediate Postoperative
3

Time of procedure

A calibrated stop watch will be used to record the time of the procedure. The recording time will start from the administration of anesthesia until the end of the procedure.

Time frame
Immediate Postopertive

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

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