Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)
1 other identifier
interventional
16
1 country
1
Brief Summary
melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties. the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated
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
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 3, 2019
CompletedFirst Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2020
CompletedDecember 17, 2020
December 1, 2020
1 year
November 6, 2020
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
change Implant stability
The result is presented as an ISQ value of 1-100. The acceptable stability range lies between 55-85 ISQ. The higher the ISQ, the more stable the implant
at baseline and 6 months
change in bone density
radiographical evaluation using CBCT
at baseline, 1 month and 6 months
change in vertical bone height
radiographical evaluation using CBCT
at baseline, 1 month and 6 months
change in marginal bone level
radiographical evaluation using CBCT
at baseline, 1 month and 6 months
Secondary Outcomes (2)
Postoperative pain
after 1 week
Postoperative swelling
after 1 week
Study Arms (2)
Melatonin and hyaluronic acid and sinus membrane elevation
EXPERIMENTALmelatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement
sinus membrane elevation without any materials
ACTIVE COMPARATORno materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.
Interventions
3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.
No materials will be placed at the sinus space.
Eligibility Criteria
You may qualify if:
- Age range will be between (30 - 50) years old.
- Patients with missed one or more of posterior teeth with minimum residual bone height 5 mm
- Adequate inter-occlusal space of at least 8 mm
You may not qualify if:
- Maxillary sinus diseases.
- Previous sinus surgery like the Caldwell-Luc operation.
- History of chemotherapy or radiotherapy to maxilla.
- Presence of Underwood's septa/severe sinus floor convolutions.
- Systemic disease affecting bone metabolism.
- Uncontrolled diabetes mellitus.
- Heavy smokers.
- Para functional habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 12, 2020
Study Start
December 3, 2019
Primary Completion
December 7, 2020
Study Completion
December 7, 2020
Last Updated
December 17, 2020
Record last verified: 2020-12