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Evaluation of Melatonin Application of Immediate Dental Implant

Clinical Evaluation of Topical Melatonin Application on Implant Stability of Immediate Dental Implant in Anterior & Premolar Region in Systemically Healthy Patients (Randomized Clinical Trial)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03689998
Enrollment
24
Registered
2018-10-01
Start date
2019-09-30
Completion date
2021-05-30
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Dental Implant

Keywords

immediate implant, melatonin, atrumatic extraction

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 .

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.

Interventions

DEVICEimmediate implant placement

immediate implant placement in freshly extraction socket

DRUGMelatonin

topical application of melatonin

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
implant stability6 monthsmeasuring implant stability using ostell

Secondary

MeasureTime frameDescription
Soft tissue healing10 daysmeasuring 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
Post operative pain10 daysmeasuring the post operative pain by visual analog scale from 1 to 10

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026