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Clinical Trials/NCT06580483
NCT06580483CompletedNot Applicable

Comparative Assessment of Two Filling Materials As Restorative Options for Tooth-tissue Supported Overdenture: a Split-mouth Randomized Trial

Delta University for Science and Technology1 site in 1 country28 target enrollmentStarted: March 20, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Wear depth

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A tooth (on one side) supporting complete overdenture

Experimental

The tooth is prepared to receive a restoration

Intervention: amalgam restoration (Other)

A tooth (on the other side) supporting complete overdenture

Active Comparator

The tooth is prepared to receive another restoration

Intervention: nano-composite (Other)

Outcomes

Primary Outcomes

Wear depth

Time Frame: 36 months

For each patient, a scan of the abutments was performed using intra-oral scanner in the day of overdenture insertion and another scan was performed after 36m follow up periods and then both scans are compared

Survival of the restoration

Time Frame: 36 months

Restoration survival was assessed according to the criteria approved by the FDI World Dental Federation (FDI) Scientific Committee in 2007 and the General Assembly in 2008 as criteria specifically developed for use in clinical trials.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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