Immediate Functional Versus Non Functional Implant Loading in the Mandible
A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)
1 other identifier
interventional
16
1 country
1
Brief Summary
comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (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 2019
Shorter than P25 for not_applicable
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
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2020
CompletedFirst Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedAugust 20, 2020
August 1, 2020
6 months
August 18, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pain score
Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be
immediately Postoperatively
Change in crestal bone loss
CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss
immediately Postoperatively and after 4 months
Study Arms (2)
immediate functional loading with temporary crowns
EXPERIMENTALpatients were rehabilitated with immediate functionally loaded implants.
immediate non functional loading with temporary crowns
EXPERIMENTALpatients were rehabilitated with immediate non-functionally loaded implants.
Interventions
Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.
implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.
Eligibility Criteria
You may qualify if:
- Adult patients aged (20-40) years old.
- Missing Posterior tooth or teeth indicated for implant placement.
- Residual alveolar ridge at least 10 mm high and at least 4 mm wide.
You may not qualify if:
- Systemic diseases that will contraindicate the surgery.
- Poor Oral Hygiene.
- The patient refuses to undergo the surgery.
- Parafunctional habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 20, 2020
Study Start
December 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 29, 2020
Last Updated
August 20, 2020
Record last verified: 2020-08