Assessment of Two Filling Materials for Teeth-tissue Supported Overdenture

NCT ID: NCT06580483

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-20
• Study Completion Date: 2024-06-15

Brief Summary

Methods: 28 patients with bilateral remaining first premolar in the maxillary or mandibular arch were enrolled in the study. Dome shaped preparations of the abutments were performed. The amalgam and composite restorations were randomly assigned to either the right or left remaining premolar; then conventional steps of overdenture fabrication and insertion were accomplished. Patients were followed up for 3 years.

Detailed Description

For all cases, root planning and supra- and subgingival scaling were carried out utilizing an ultrasonic scaler. For all cases, all teeth were cleaned, shaped, and obturated during the patients' first visit. Local anaesthesia was achieved by local infiltration. After anaesthesia, an endodontic access cavity was established. Canals were prepared using the crowndown technique. The ideal working length was determined using an electronic apex locator and periapical radiographs. The canals were cleaned and shaped. The final instrumentation size was determined as three sizes larger than the first file binding at the working length. Master apical files ranged from #25 to #50, depending on both root anatomy and initial diameter of the root canal.Irrigation was always performed with 5.25% NaOCl solution. Obturation using gutta-percha. The master gutta-percha cone was coated with AH Plus, obturation was carried out utilizing the lateral compaction technique. Afterwards, selective etching of enamel for 30 seconds then rinsing and dryness were done followed by application of universal bonding agent with agitation action which was then light cured for 20 seconds. It was then followed by core buildup with light cured Nano-filled composite body.. As for the amalgam, high-copper non-gamma 2 spherical and lathe cut amalgam was used. For all patients, fabrication of new dentures was employed.

Data were statistically described in terms of mean, standard deviation (SD), 95% CI, median and range. Data were tested for the normal assumption using Kolmogorov Smirnov test. Comparison between the study groups was done using Student t test for independent samples. Two-sided p values less than 0.05 was considered statistically significant. IBM SPSS. Survival analysis was done using Kaplan Maier statistics

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A tooth (on one side) supporting complete overdenture

The tooth is prepared to receive a restoration

Group Type: EXPERIMENTAL

amalgam restoration

Intervention Type: OTHER

An abutment tooth is restored on a side by amalgam plug

A tooth (on the other side) supporting complete overdenture

The tooth is prepared to receive another restoration

Group Type: ACTIVE_COMPARATOR

nano-composite

Intervention Type: OTHER

An abutment tooth is restored on a side by nano-composite

Interventions

amalgam restoration

An abutment tooth is restored on a side by amalgam plug

Intervention Type: OTHER

nano-composite

An abutment tooth is restored on a side by nano-composite

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Presented with partially edentulous maxillary and mandibular arches particularly with bilaterally remaining any of these teeth ; #33 #34 #35 #43 #44 #45 #13 # 14#15 #23 # 24 #25
• Good periodontal support and grade I mobility.
• They were medically free.

Exclusion Criteria

• Medically compromised
• Grade II and grade III mobility

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delta University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wafaa I Ibrahim

Role: PRINCIPAL_INVESTIGATOR

Assoc. Prof.

Locations

Delta University for Science & Technology

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

FODMRC-202100102

Identifier Type: -

Identifier Source: org_study_id