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Clinical Evaluation of Different Resin Composite Restorations

Sponsor
Al-Azhar University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05418400
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.

Condition or Disease Intervention/Treatment Phase
  • Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Study of Clinical Criteria of Different Resin Composite Restorations Among Lower Molars
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 2, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: bulkfill composites

sonic fill 3 & PALFIQUE bulk flow bulk fill composite

Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
dental filling materials
Active Comparator: incremental composites

Neo spectra & Clear fill AP-X incremental composites

Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
dental filling materials

Outcome Measures

Primary Outcome Measures

  1. Post operative sensitivity [along one year]

    restorations will be evaluated the according to the modified United States Public Health Service (USPHS)

  2. marginal discoloration [along one year]

    restorations will be evaluated the according to the modified United States Public Health Service (USPHS)

  3. marginal adaptation [along one year]

    restorations will be evaluated the according to the modified United States Public Health Service (USPHS)

  4. recurrent caries [along one year]

    restorations will be evaluated the according to the modified United States Public Health Service (USPHS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

inclusion criteria of participants:

  • Male gender

  • Good oral hygiene

  • Only Cooperative patient

  • Medically free patient

  • Age range 18-24

inclusion criteria of the teeth:

  • Vital teeth with no periapical lesion or radiolucency.

  • Prepared cavity with no undermined enamel walls.

  • Functioning tooth with presence of an opposing.

  • Healthy periodontium.

Exclusion Criteria:

  • exclusion criteria of participants:

  • Old age patients

  • Patients have systemic disease or sever medically compromised

  • Patients with bruxism, clenching or temporomandibular joint disorder.

  • Por oral hygiene

exclusion criteria of teeth:

  • Teeth with periapical lesions.

  • Teeth with visible cracks.

  • Teeth with mobility.

  • Non-functioning tooth with no opposing tooth.

  • Heavy occlusion or signs of sever attrition.

  • Tooth with Periodontal affection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dental medicine Al Azhar university Cairo Egypt

Sponsors and Collaborators

  • Al-Azhar University

Investigators

  • Study Chair: Nady Ebrahem Hasanin, professor, Faculty of dental medicine Al Azhar university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Basha, principal investigator, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05418400
Other Study ID Numbers:
  • 732/385
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Basha, principal investigator, Al-Azhar University
composite resin
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Jun 14, 2022