Clinical trial NCT06580483: Assessment of Two Filling Materials for Teeth-tissue Supported Overdenture
Official title: Comparative Assessment of Two Filling Materials As Restorative Options for Tooth-tissue Supported Overdenture: a Split-mouth Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: overdenture
nanocomposite
Amalgam
Survival
Wear
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Wear depth
timeFrame: 36 months
measure: Survival of the restoration
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Delta University for Science & Technology
Study officials:
affiliation: Assoc. Prof.
name: Wafaa I Ibrahim
role: PRINCIPAL_INVESTIGATOR
References: