Clinical trial NCT06596707: Contact Tightness of Zirconomer Versus Nanohybrid Composite in Occlusoproximal Cavities in Molars
Official title: Comparison of Proximal Contact Tightness of Zirconia Reinforced Glass Ionomer Versus Conventional Nanohybrid Resin Composite: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth
Keywords: Zirconomer
Glass Ionomer
Contact tightness
Occlusoproximal cavities
Resin composite
Class II
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative material. Current tooth-colored restorative materials are not condensable and there is shrinkage with setting. The aim of this study is to compare the proximal contact tightness of zirconia reinforced glass ionomer versus conventional nanohybrid resin composite when used in class II cavities.


Eligibility criteria: Eligibility Criteria of participants:

Inclusion Criteria of participants:

* Patients with occlusoproximal caries in molars classified as ICDAS III or IV.
* 19-35 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or temporomandibular joint disorders.

  b- Eligibility Criteria of teeth:

Inclusion Criteria of teeth:

* Occlusoproximal caries in molars classified as ICDAS III or IV.
* Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
* Intact contact with opposing teeth.
* Teeth with no previous restorations in other surfaces.

Exclusion criteria of the teeth:

* Extensive carious lesions
* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Sever periodontal affection.

Primary outcomes:
measure: Contact Tightness
timeFrame: baseline, 3 months, 6 months, 9 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo university
state: Manyal
Study officials:
affiliation: lecturer of conservative dentistry, Cairo university
name: Alaa F Abdelsalam, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of conservative dentistry, Cairo university
name: Hadier M Gad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of conservative dentistry, Cairo University
name: Manar A Elmokanen, PhD
role: PRINCIPAL_INVESTIGATOR
References: