Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

Hams Hamed Abdelrahman16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Edentulous; Alveolar Process, Atrophy

Interventions

Melatonin and hyaluronic acid and sinus membrane elevationOTHER

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 materialsPROCEDURE

No materials will be placed at the sinus space.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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

Time frame: at baseline and 6 months

change in bone density

radiographical evaluation using CBCT

Time frame: at baseline, 1 month and 6 months

change in vertical bone height

radiographical evaluation using CBCT

Time frame: at baseline, 1 month and 6 months

change in marginal bone level

radiographical evaluation using CBCT

Time frame: at baseline, 1 month and 6 months

Secondary Outcomes

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).

Time frame: after 1 week

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).

Time frame: after 1 week

Data from ClinicalTrials.gov

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