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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin and hyaluronic acid and sinus membrane elevation | Experimental | melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement |
|
| sinus membrane elevation without any materials | Active Comparator | no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin and hyaluronic acid and sinus membrane elevation | Other | 3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | after 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| sinus membrane elevation without any materials | Procedure | No materials will be placed at the sinus space. |
|
| 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). | after 1 week |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |