Clinical trial NCT04716517: Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult With Class V Carious
Official title: Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult Patients With Class V Carious Lesions Over One Year Period: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.

Detailed description: In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.

The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed

Eligibility criteria: Inclusion criteria:

* Patients with High caries risk.
* Patients with poor oral hygiene.
* Patients with untreated cervical caries lesion.
* patient aging ≥18 years.
* Absence of tooth mobility
* Absence of abnormal occlusion.
* Patients with good likelihood of recall availability.

Exclusion criteria:

* Patients with cervical caries lesions need crown restoration.
* Non-vital teeth.
* Evidence of parafunctional habits.
* Teeth supporting removable prosthesis.
* Periapical Abscess or Fistula.
* Patients with systemic disease.
* Patients with xerostomia.
* Participants with a history of allergy to any component of restorations will be used in the study.

Primary outcomes:
measure: (Marginal adaptation)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: