Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

NCT ID: NCT04625179

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2020-12-07

Brief Summary

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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

Detailed Description

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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.

Conditions

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Edentulous; Alveolar Process, Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Melatonin and hyaluronic acid and sinus membrane elevation

Intervention Type 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.

sinus membrane elevation without any materials

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

Group Type ACTIVE_COMPARATOR

sinus membrane elevation without any materials

Intervention Type PROCEDURE

No materials will be placed at the sinus space.

Interventions

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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.

Intervention Type OTHER

sinus membrane elevation without any materials

No materials will be placed at the sinus space.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Maxillary sinus augmentation

Identifier Type: -

Identifier Source: org_study_id