Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Completed

CT.gov ID

NCT04625179

Collaborator

(none)

Enrollment

Location

Arms

12.2

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Edentulous; Alveolar Process, Atrophy	Other: Melatonin and hyaluronic acid and sinus membrane elevation Procedure: sinus membrane elevation without any materials	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 3, 2019

Actual Primary Completion Date :

Dec 7, 2020

Actual Study Completion Date :

Dec 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin and hyaluronic acid and sinus membrane elevation melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement	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.
Active Comparator: sinus membrane elevation without any materials no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.	Procedure: sinus membrane elevation without any materials No materials will be placed at the sinus space.

Arm

Intervention/Treatment

Experimental: Melatonin and hyaluronic acid and sinus membrane elevation

melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement

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.

Active Comparator: sinus membrane elevation without any materials

no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.

Procedure: sinus membrane elevation without any materials

No materials will be placed at the sinus space.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT04625179

Other Study ID Numbers:

Maxillary sinus augmentation

First Posted:

Nov 12, 2020

Last Update Posted:

Dec 17, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrophy

Melatonin

Hyaluronic Acid

Study Results

No Results Posted as of Dec 17, 2020