Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted
Soft Tissue Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Casted One (RCT, Split Mouth Design)
1 other identifier
interventional
12
1 country
1
Brief Summary
comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method
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 Oct 2020
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
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedOctober 8, 2020
October 1, 2020
1 year
August 26, 2020
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Soft Tissue Changes Assessment
Primary outcome is the probing depth which will be measured using the periodontal probe (unit mm) around the implant to check the changes that may occur in the peri-implant soft tissues
12 months
Study Arms (2)
electric welded metal framework
EXPERIMENTALconventional casted metal framework
EXPERIMENTALInterventions
welding metal framework to the implants in completely edentulous maxilla by electric welding device intraorally
Eligibility Criteria
You may qualify if:
- Ages range from 45 to 65 years old.
- Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
- The patients must be completely edentulous.
- The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
- Patients with good oral hygiene.
- Complete denture wearer.
- Adequate inter arch space for screw retained prosthesis.
- Absence of any intra-oral pathological condition.
You may not qualify if:
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappy ridge.
- Parafunctional habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University , Faculty of dentistry
Cairo, 11553, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
faculty of dentistry,cairo university Cairo university
CONTACT
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
- principal investigator
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 10, 2020
Study Start
October 1, 2020
Primary Completion
October 1, 2021
Study Completion
November 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share