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Clinical Trials/NCT06127017
NCT06127017Not yet recruitingNot Applicable

Comparing Marginal Bone Loss for Immediately Loaded Implants in Maxillary Full Arch Interim Prosthesis Using Welded Titanium Bar Versus Polyetheretherketone Bar

Ain Shams University0 sites14 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
14
Primary Endpoint
marginal bone loss measurement

Study Overview

Brief Summary

Fourteen completely edentulous patients will be randomly allocated into two parallel arm groups. For both groups virtual implant planning will be done and surgical guide will be planned and printed. An immediate interim full arch PMMA prosthesis will be virtually designed and printed for both groups. For the Intraoral welding group, seven patients will receive immediately loaded interim fixed full arch prosthesis splinted by intraoral welded bar. While for PEEK group in which seven patients will receive immediately loaded interim fixed full arch prosthesis splinted by PEEK bar. Marginal bone loss will be clinically evaluated at four, six months follow up period using CBCT.

Detailed Description

Study settings The study will be conducted in Oral & Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. Sample size calculation Fourteen patients will be selected to share in this study from the outpatient clinic of Prosthodontics Department, Faculty of Dentistry, Ain-Shams University. G power program (3. 1) was used for calculations of sample size. Statistical calculator was based on 95% confidence interval and power of the study 80% with α error 5%.

Based on a previous study (Degidi, Marco, Diego Nardi, and Adriano Piattelli. "Prospective study with a 2-year follow-up on immediate implant loading in the edentulous mandible with a definitive restoration using intra-oral welding), which showed that the mean of marginal bone growth was 0.21 in one group compared to the second group. Using un paired t test the results were found to be significant. So, it was relied upon in this study. Based on this assumption, sample size was calculated according to these values producing a minimal sample size of fourteen patients being enough to find such a difference. Study procedures

  1. Randomization and allocation concealment techniques Computer-generated random numbers will be used for simple randomization of the subjects. Therefore, the participants will be randomly allocated into two groups: intraoral welding group and PEEK group. The allocation ration will be set 1:1. Allocation concealment will be done using opaque sealed envelopes.
  2. Details of intervention:

Ethical approval will be granted by the Research Ethical Committee, Faculty of Dentistry, Ain Shams University (FDASUREC). All patients will be informed in details about the nature of investigation and the aim of the study. Patient's data will be kept safe and confidential to protect the security and privacy of the patient information. All participants will be given notice about their privacy and their rights. 1-Patient Grouping: Fourteen patients will be enrolled in this study and randomly divided into two groups as follow Group Ⅰ: seven patients will receive immediately loaded interim fixed full arch prosthesis splinted by intraoral welded bar. Group Ⅱ: seven patients will receive immediately loaded interim fixed full arch prosthesis splinted by PEEK bar

2-Patient selection: The inclusion criteria will be systemically free completely edentulous patient ranged from 45 y to 69 years old with Class I maxillary-mandibular relationship, Normal salivary flow with normal viscosity. Residual maxillary ridge has adequate bone and covered by firm healthy mucosa. The excluded patients will include patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes or under bisphosphonate treatment, Patients with poor oral hygiene. Patients with abnormal oral habits as (bruxism, clenching, tongue thrusting).Potentially uncooperative patients who are not willing to go through the proposed interventions. 3-Clinical steps:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • .medically free. .class I maxillomandibular relation. .normal salivary flow.
  • residual ridge has adequate mucosa
  • covered with firm healthy mucosa.

Exclusion Criteria

  • . poor oral hygiene. .uncooperative patients. .patients with abnormal oral habits.

Outcomes

Primary Outcomes

marginal bone loss measurement

Time Frame: total frame of 6 months with the following frequencies :at base line, after 4 months and after 6 months.

marginal bone loss will be measured using cone beam computed tomography at the buccal, palatal, mesial and distal aspect of the implant and an average value will be calculated for each implant.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

soha saeid mohammed

Assistant lecturer, Oral and maxillofacial prosthodontics department

Ain Shams University

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