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Completed

NCT Number: NCT04625179

Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

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

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Key information

Conditions

Edentulous; Alveolar Process, Atrophy Atrophy Mouth Diseases Mouth, Edentulous Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin and hyaluronic acid and sinus membrane elevation

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

Procedure

No materials will be placed at the sinus space.

Primary outcomes

  1. change Implant stability

    Time frame: 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

  2. change in bone density

    Time frame: at baseline, 1 month and 6 months

    radiographical evaluation using CBCT

  3. change in vertical bone height

    Time frame: at baseline, 1 month and 6 months

    radiographical evaluation using CBCT

  4. change in marginal bone level

    Time frame: at baseline, 1 month and 6 months

    radiographical evaluation using CBCT

Secondary outcomes

  1. Postoperative pain

    Time frame: 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).

  2. Postoperative swelling

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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