Clinical trial NCT05617703: Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year
Official title: Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries Class v
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups with a 1:1 allocation using computer generated randomization list (www.random.org).
Primary purpose: TREATMENT

Brief summary: The goal of this \[type of study: Randomized clinical trial\] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year.

in adult patients with cervical carious lesion.

The main question it aims to answer are:

• Will the use of glass ionomer with advanced glass hybrid technology, achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass ,or Resin Modified Glass Ionomer have better mechanical and estheic properties over one year in adult patients with cervical carious lesions ?

Participants 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, their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration that will be received after class V cavity preparations for carious cervical lesions.

Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated with rubber dam.

The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received advanced glass hybrid glass ionomer . 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 FDI criteria criteria in terms of esthetic and mechanical properties . The information that will be obtained will be collected and statistically analyzed.

Detailed description: Eligibility criteria

The participants were chosen according to the following eligibility criteria:

Inclusion criteria Exclusion criteria

Patient inclusion:

1. Patients aging ≥18 years.
2. Patients with High caries risk.
3. Patients with untreated cervical caries lesion that need restorative treatment.
4. Males or females
5. No abnormal occlusion for selected teeth.
6. Patients with good likelihood of recall availability

Tooth inclusion:

1. Permanent teeth.
2. Absence of mobility.
3. Primary carious lesions.
4. Vital with positive reaction to thermal stimulus .

Patient exclusion:

1. Participants with general/systemic illness.
2. Concomitant participation in another research study.
3. Inability to comply with study procedures.
4. Heavy bruxism habits.
5. Last experience with allergic reactions against any components of the used materials.
6. Patients receiving orthodontic treatment.
7. Teeth supporting removable prosthesis
8. Patients with cervical caries lesions that need crown restoration.
9. Xerostomia.

Tooth exclusion:

1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
2. Non-vital teeth.
3. Periapical Abscess or Fistula.

   * Outcomes:

For each recall examination, two independent evaluators will perform the direct clinical evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.

Eligibility criteria: Inclusion Criteria:

* Patient inclusion:

  1. Patients aging ≥18 years.
  2. Patients with High caries risk.
  3. Patients with untreated cervical caries lesion that need restorative treatment.
  4. Males or females
  5. No abnormal occlusion for selected teeth.
  6. Patients with good likelihood of recall availability

Tooth inclusion:

1. Permanent teeth.
2. Absence of mobility.
3. Primary carious lesions.
4. Vital with positive reaction to thermal stimulus .

Exclusion Criteria:

* 1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials.

  6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia.

Tooth exclusion:

1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
2. Non-vital teeth.
3. Periapcal Abscess or Fistula.

Primary outcomes:
measure: FDI criteria
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: