Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

Edentulous; Alveolar Process, Atrophy Clinical Trial

Official title:

Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625179
• Other study ID #: Maxillary sinus augmentation
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: December 7, 2020

Study information

• Verified date: December 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Edentulous; Alveolar Process, Atrophy

Intervention

Other:
• Melatonin 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.

Procedure:
• sinus membrane elevation without any materials
No materials will be placed at the sinus space.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in bone density	radiographical evaluation using CBCT	at baseline, 1 month and 6 months
Primary	change in vertical bone height	radiographical evaluation using CBCT	at baseline, 1 month and 6 months
Primary	change in marginal bone level	radiographical evaluation using CBCT	at baseline, 1 month and 6 months
Secondary	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
Secondary	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