Comparing Marginal Bone Loss for Immediately Loaded Implants in Maxillary Full Arch Interim Prosthesis Using Welded Titanium Bar Versus Polyetheretherketone Bar
1 other identifier
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedNovember 24, 2023
November 1, 2023
8 months
November 7, 2023
November 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
marginal bone loss measurement
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.
total frame of 6 months with the following frequencies :at base line, after 4 months and after 6 months.
Study Arms (2)
Titanium bar
PLACEBO COMPARATOR6 implants in each participant will be immediately loaded and splinted with intraorally welded titanium bar.
PEEK bar
ACTIVE COMPARATOR6 implants in each participant will be immediately loaded and splinted with PEEK bar.
Interventions
splinting of dental implants will be done in the placebo comparator group by welding a titanium bar intraorally to the temporary sleeves attached to the implants.
in the active comparator group ,the PEEK bar will be attached to the temporary sleeves using flowable composite resin material.
Eligibility Criteria
You may qualify if:
- medically free. .class I maxillomandibular relation. .normal salivary flow.
- residual ridge has adequate mucosa
- covered with firm healthy mucosa.
You may not qualify if:
- poor oral hygiene. .uncooperative patients. .patients with abnormal oral habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
soha s elsaeid
Assistant lecturer ,Faculty of Dentistry, Ain Shams university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer, Oral and maxillofacial prosthodontics department
Study Record Dates
First Submitted
November 7, 2023
First Posted
November 13, 2023
Study Start
December 1, 2023
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
November 24, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share