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Evaluation of Melatonin Application of Immediate Dental Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03689998
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : January 28, 2020
Information provided by (Responsible Party):
ahmed magdy Mahmoud Abdellatif, Cairo University

Brief Summary:

The presence of periapical pathology, the absence of kera¬tinized tissue and lack of complete soft tissue closure over the extraction socket have been reported a drawbacks of immediate implant placement .

As mentioned before the presence of periapical pathology is one of the limitation of immediate implant placement, melatonin has an action against Gram-positive and Gram-negative microorganisms with a higher efficacy on the latter; it also showed efficacy against different strains of antibiotic-resistant bacteria.

Melatonin was found to be effective in several cases as an anxiolytic and analgesic agent. It also reduce inflammatory pain by blocking the production of nitric oxid Also the lack of complete soft tissue closure over the extraction socket is one of the drawbacks of immediate implant placement; melatonin induces the production of interleukin-1, tumor necrosis factor (TNF)-α and transforming growth factor (TGF). In addition, melatonin is an immunomodulator and a neuroendocrine hormone, and stimulates both monocyte cytokine and fibroblast proliferation, which influence angiogenesis and wound healing..

As the initial implant stability is one of the criteria of implant success, Melatonin was found to increase new cortical bone width and length during the early stages (15 and 30 days), and it also promoted early cell differentiation. Melatonin acted on the bone as a local growth factor .

Condition or disease Intervention/treatment Phase
Immediate Dental Implant Device: immediate implant placement Drug: Melatonin Phase 4

Detailed Description:
Melatonin is chemically recognized as N-acetyl-5-methoxytryptamine. It is a compound occurring naturally in plants, microbes and animals. The circulating level of the melatonin hormone in animals shows interesting variations, by entertainment of variable biological functions in a daily cycle "circadian rhythm". Melatonin called hormone of night is secreted by the pineal gland, and its plasma levels concentration are 50 folds higher in night in comparison to daytime. A variety of peripheral cells play a role in production of melatonin such as epithelial cells, bone marrow cells, and lymphocytes. Though melatonin is a hormone, it does not act on a specific organ, it has several functions; stimulation of the synthesis of type I collagen fibers, regulation of the body temperature, sexual development, antioxidant scavenging and detoxifying free radicals thus inhibiting the process of bone resorption through interfering with the function of osteoclasts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Topical Melatonin Application on Implant Stability of Immediate Dental Implant in Anterior & Premolar Region in Systemically Healthy Patients (Randomized Clinical Trial)
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: implant placement with melatonine
immediate implant placement with melatonine
Device: immediate implant placement
immediate implant placement in freshly extraction socket
Other Name: post extraction dental implant

Drug: Melatonin
topical application of melatonin

Active Comparator: immediate implant placement alone
immediate implant placement alone
Device: immediate implant placement
immediate implant placement in freshly extraction socket
Other Name: post extraction dental implant

Primary Outcome Measures :
  1. implant stability [ Time Frame: 6 months ]
    measuring implant stability using ostell

Secondary Outcome Measures :
  1. Soft tissue healing [ Time Frame: 10 days ]
    measuring the soft tissue healing by likert scale which classify the healing in to 5 score ( score 0 ,1 , 2 , 3 , 4 ( 0 indicate complete healing & 4 indicate incomplete healing

  2. Post operative pain [ Time Frame: 10 days ]
    measuring the post operative pain by visual analog scale from 1 to 10

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pt. eligible for implant placement after 18 years
Accepts Healthy Volunteers:   Yes

Inclusion criteria

  1. Age: 18-60.
  2. Healthy patients
  3. Non Smoker
  4. Patients with adequate bone volume for immediate dental implant procedure.
  5. Patients with absence of any periapical pathosis.

Exclusion criteria:

  1. Heavy smokers.
  2. Systemic disease that contraindicates implant placement or surgical procedures.
  3. No or poor patient's compliance.
  4. Psychological problems.
  5. Pathology at the site of intervention.
  6. Pregnancy females.
  7. Patient refuses to sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03689998

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Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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Study Chair: Mona Shoeib, Phd Cairo University
Study Chair: Mona Darhous, Phd Cairo University
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Responsible Party: ahmed magdy Mahmoud Abdellatif, associate lecturer, Cairo University Identifier: NCT03689998    
Other Study ID Numbers: per21085
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: i will check with the study chair

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by ahmed magdy Mahmoud Abdellatif, Cairo University:
immediate implant
atrumatic extraction
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants