Edentulous; Alveolar Process, Atrophy
Conditions
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.
Interventions
OTHERMelatonin and hyaluronic acid and sinus membrane elevation
3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.
PROCEDUREsinus membrane elevation without any materials
No materials will be placed at the sinus space.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change Implant stability | at baseline and 6 months | 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 | at baseline, 1 month and 6 months | radiographical evaluation using CBCT |
| change in vertical bone height | at baseline, 1 month and 6 months | radiographical evaluation using CBCT |
| change in marginal bone level | at baseline, 1 month and 6 months | radiographical evaluation using CBCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | after 1 week | 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 | after 1 week | 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). |
Countries
Egypt
Outcome results
None listed