Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05149209

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Procedure: cervical restoration	N/A

Detailed Description

two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.

Examination and selection of all patients will be done according to inclusion and exclusion criteria.
A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The participants will be blinded to the technique used since the patient will attend the same number of visits and he can not differentiate between different restorative materials. The operator cannot be blinded because of the difference in the application procedures of each restorative material. The outcome assessor will be blinded to the material used. This will be performed by M.S. and Y.H. Therefore the assessors mustn't be included in the preclinical assessment.

Primary Purpose:

Treatment

Official Title:

One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.

Anticipated Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA). ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions. It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives.	Procedure: cervical restoration A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done.
Active Comparator: Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer. S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries.	Procedure: cervical restoration A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done.

Arm

Intervention/Treatment

Experimental: Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).

ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions. It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives.

Procedure: cervical restoration

A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done.

Active Comparator: Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).

Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer. S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries.

Procedure: cervical restoration

Outcome Measures

Primary Outcome Measures

Marginal adaptation [one year]
The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed

Secondary Outcome Measures

Marginal Discoloration [one year]
Clinical evaluation by visual inspection and mirror if needed using modified USPHS criteria. Restorations will be given the score: Alfa if No discoloration Bravo if Non penetrating marginal discoloration which can be polished away Charlie if Discoloration with penetration in pulpal direction.
Retention [one year]
Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria : Alfa if restoration is retained and there is no loss of restoration. Charlie if loss of restoration.
Secondary caries [one year]
Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if no recurrent caries is detected, charlie if recurrent caries is detected. .
surface texture [one year]
Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if restoration is enamel-like surface Bravo if Surface rougher than enamel, clinically acceptable Charlie if Surface is unacceptably rough.
postoperative sensitivity [one year]
Verbal evaluation by asking the patient. Restorations will be given a score according to modified USPHS criteria: Alfa if not present Bravo if sensitive but diminishing in intensity Charlie if constant sensitivity not diminishing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

a)Inclusion Criteria of participants:
Male or female gender.
Only co-operative patients will be approved to participate in the trial.
Medically free adult patients.
The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
Small to moderate cervical lesion.
Vital upper or lower teeth with no signs of irreversible pulpitis.
Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.

Exclusion Criteria:

a)Exclusion criteria of participants:
Allergic history concerning methacrylates
Pregnancy
Heavy smoking; xerostomia
Lack of compliance
Patients with disabilities.
Patients having systemic diseases or severe medically compromised.
Patients with severe bruxism, clenching, or temporomandibular joint disorders.

b)Exclusion criteria of the teeth:

Deep defects (close to the pulp, less than 1 mm distance).
Periapical pathology or signs of pulpal pathology.
Possible prosthodontic restoration of teeth.
Heavy occlusion and occlusal contacts or history of bruxism.
Pulpitis, non-vital or endodontically treated teeth.
Sever periodontal affection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nourhan Khaled Mohamed Samir	Cairo	Maadi	Egypt	11728

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nourhan Khaled Mohamed Samir, Resident at Conservative department, Cairo University

ClinicalTrials.gov Identifier:

NCT05149209

Other Study ID Numbers:

cons2021

First Posted:

Dec 8, 2021

Last Update Posted:

Dec 8, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Dec 8, 2021