Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
Primary Purpose
Edentulous; Alveolar Process, Atrophy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin and hyaluronic acid and sinus membrane elevation
sinus membrane elevation without any materials
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous; Alveolar Process, Atrophy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Melatonin and hyaluronic acid and sinus membrane elevation
sinus membrane elevation without any materials
Arm Description
melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement
no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.
Outcomes
Primary Outcome Measures
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
change in bone density
radiographical evaluation using CBCT
change in vertical bone height
radiographical evaluation using CBCT
change in marginal bone level
radiographical evaluation using CBCT
Secondary Outcome Measures
Postoperative pain
based on a 4-point verbal descriptive scale as following: no pain, mild (recognizable but not discomforting pain that required no analgesics), moderate (discomforting but bearable pain and analgesics if used were effective in relieving pain) and severe (difficult to bear and analgesics were effective in relieving pain).
Postoperative swelling
none (no inflammation), mild (intraoral swelling confined to the surgical field), moderate (extraoral swelling in the surgical zone) and severe (extraoral swelling spreading beyond the surgical zone).
Full Information
NCT ID
NCT04625179
First Posted
November 6, 2020
Last Updated
December 15, 2020
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT04625179
Brief Title
Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
Official Title
Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
16 participants with missing maxillary posterior teeth and residual alveolar ridge of at least 5 mm will be equally and randomly divided into two groups.
The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and simultaneous implant placement while the control group will not receive any materials after sinus membrane elevation and simultaneous implant placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous; Alveolar Process, Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melatonin and hyaluronic acid and sinus membrane elevation
Arm Type
Experimental
Arm Description
melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement
Arm Title
sinus membrane elevation without any materials
Arm Type
Active Comparator
Arm Description
no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.
Intervention Type
Other
Intervention Name(s)
Melatonin and hyaluronic acid and sinus membrane elevation
Intervention Description
3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.
Intervention Type
Procedure
Intervention Name(s)
sinus membrane elevation without any materials
Intervention Description
No materials will be placed at the sinus space.
Primary Outcome Measure Information:
Title
change Implant stability
Description
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
Time Frame
at baseline and 6 months
Title
change in bone density
Description
radiographical evaluation using CBCT
Time Frame
at baseline, 1 month and 6 months
Title
change in vertical bone height
Description
radiographical evaluation using CBCT
Time Frame
at baseline, 1 month and 6 months
Title
change in marginal bone level
Description
radiographical evaluation using CBCT
Time Frame
at baseline, 1 month and 6 months
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
based on a 4-point verbal descriptive scale as following: no pain, mild (recognizable but not discomforting pain that required no analgesics), moderate (discomforting but bearable pain and analgesics if used were effective in relieving pain) and severe (difficult to bear and analgesics were effective in relieving pain).
Time Frame
after 1 week
Title
Postoperative swelling
Description
none (no inflammation), mild (intraoral swelling confined to the surgical field), moderate (extraoral swelling in the surgical zone) and severe (extraoral swelling spreading beyond the surgical zone).
Time Frame
after 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
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Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
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