Evaluation of Melatonin Application of Immediate Dental Implant

Study Overview
=================
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.

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)

Conditions
-----------------
Immediate Dental Implant

Intervention / Treatment
-----------------
* Device: immediate implant placement
* Drug: Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age: 18-60. Healthy patients Non Smoker Patients with adequate bone volume for immediate dental implant procedure. Patients with absence of any periapical pathosis. Exclusion criteria: Heavy smokers. Systemic disease that contraindicates implant placement or surgical procedures. No or poor patient's compliance. Psychological problems. Pathology at the site of intervention. Pregnancy females. Patient refuses to sign the informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: implant placement with melatonine<br>immediate implant placement with melatonine | Device: immediate implant placement<br>* immediate implant placement in freshly extraction socket<br>* Other names: post extraction dental implant;Drug: Melatonin<br>* topical application of melatonin<br>|
| Active Comparator: immediate implant placement alone<br>immediate implant placement alone | Device: immediate implant placement<br>* immediate implant placement in freshly extraction socket<br>* Other names: post extraction dental implant;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | measuring implant stability using ostell | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue healing | 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 | 10 days | 
| Post operative pain | measuring the post operative pain by visual analog scale from 1 to 10 | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate implant, melatonin, atrumatic extraction