Crestal Bone Loss in Mandibular Telescopic Overdentures. Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings.
2 other identifiers
interventional
30
1 country
1
Brief Summary
The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction. All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 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
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 9, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedOctober 15, 2024
October 1, 2024
1 year
October 9, 2024
October 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Crestal bone loss.
The aim of this study was to evaluate crestal peri implant bone loss in mandibular telescopic implant retained overdenture with milled titanium, milled poly-ether ketone ketones and 3D printed chrome cobalt secondary copings. Crestal bone loss evaluated every three months using standardized digital periapical radiograph at time of overdenture insertion, 3, 6, 9, and after 12 months from overdenture use.
one year
Study Arms (3)
Milled Titanium secondary copings
ACTIVE COMPARATOR3D printed chrom cobalt copings.
EXPERIMENTALMilled Poly-ether Ketone Ketones copings.
EXPERIMENTALInterventions
Telescopic overdenture with two dental implants in intraforaminal area for mandible.
Eligibility Criteria
You may qualify if:
- Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
- Adequate amount of interarch space of at least 12mm.
- Age range from 55 to 75 years old age.
You may not qualify if:
- Systemic and metabolic diseases that may affect osseointegration.
- Patients receiving bisphosphonates therapy.
- Patients under radiotherapy or chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Minia Universitycollaborator
Study Sites (1)
EL Minia University
Minya, Egypt
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer of prosthodontics
Study Record Dates
First Submitted
October 9, 2024
First Posted
October 15, 2024
Study Start
August 1, 2023
Primary Completion
August 1, 2024
Study Completion
October 1, 2024
Last Updated
October 15, 2024
Record last verified: 2024-10