Patient Satisfaction, Peri-implant Parameters and Crestal Bone Evaluation of PEEK (Polyetheretherketone) Abutments Versus Zirconium Abutments Restored With PEEK Based Superstructure
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The aim of the study is to evaluate the patients' satisfaction, peri-implant parameters (bleeding on probing, probing depth and plaque index) and crestal bone resorption of implants restored with PEEK abutments restored with PEEK superstructure compared to implants restored with zirconia abutments with PEEK superstructure.the NULL HYPOTHESIS;There is no difference between the two groups
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 Jan 2019
Typical duration for not_applicable
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
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 22, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedOctober 22, 2018
October 1, 2018
2 years
September 25, 2018
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
change in Patients satisfaction: VAS
Visual analogue scale (VAS) a numerical scale from 0 - 10 , 0 = not satisfied and 10 = highly satisfied
baseline, 3, 6 and 12 months (1 year)
Secondary Outcomes (3)
Change in bleeding in probing
baseline, 3 , 6 and 12 months (1 year)
Change in periodontal probing depth
baseline, 3 , 6 and 12 months (1 year)
Change in Plaque accumilation
baseline, 3 , 6 and 12 months (1 year)
Other Outcomes (1)
change in crestal bone resorption
baseline, 3 , 6 and 12 months (1 year)
Study Arms (2)
PEEK abutment
EXPERIMENTALPEEK abutment restored with PEEK superstructure
Zirconia abutment
EXPERIMENTALzirconia abutment restored with PEEK superstructure
Interventions
Implants will be restored with abutments made from polyetheretherketone (PEEK) abutments and a PEEK superstructure
Imolants will be restored with zirconia abutments and a PEEK superstructure
Eligibility Criteria
You may qualify if:
- patients above 18 years old
- Patients able to read and sign the informed consent.
- Medically free patients or with controlled systemic condition.
- Missing tooth/teeth in the esthetic zone
- Minimum bucco-lingual bone width of 6mm, evaluated using CBCT.
- Good oral hygiene and favourable occlusion
- Cooperative and motivated Patients.
You may not qualify if:
- Under 18 years old
- Illiterate, unable of comprehending or signing the informed consent form
- Uncontrolled systemic disease (e.g. Diabetes or hypertension) or debilitated health condition
- Pregnancy
- Poor oral hygiene or unfavorable occlusion
- Uncooperative, not willing to return for follow up visits
- Insufficient bone quantity or quality for implant placement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Officials
- STUDY DIRECTOR
Amina Zaki, Professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
September 25, 2018
First Posted
October 22, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2021
Study Completion
July 1, 2021
Last Updated
October 22, 2018
Record last verified: 2018-10