The Effect of Melatonin Application Following Removal of Impacted Third Molar

Study Overview
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Brief Summary
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In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.

Official Title
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Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: 3 mg melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18ys no systemic disease impacted mandibular third molar class II position B on Pell- Gregory classification Exclusion Criteria: history of metabolic or systemic diseases affecting bone or healing process, local infection, tobacco use, oral contraceptive, pregnancy and lactation patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study arm<br>patients will undergo surgery to remove impacted lower third molar and receive Melatonin (3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%) in the socket following removal of the impacted third molar | Drug: 3 mg melatonin<br>* patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%<br>* Other names: melatonin group;|
| Placebo Comparator: controlled arm<br>patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %). | Drug: Placebo<br>* patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%<br>* Other names: cellulose group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density | The bone density within the extraction socket was measured using software of cone beam | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoprotegerin (OPG) | Human Osteoprotegerin (OPG) ELISA Kit was used to detect OPG levels.The changes in OPG in the whole group in the predetermined period immediate postoperative , after 4 week,and 6months | 4weeks postoperatively | 
| pain sensation | a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10). | 7 days postoperative | 
| swelling | a tape measure, from the tragus to the corner of the mouth. | 7 days postoperative | 
| trismus | measuring the distance between incisal edges of upper and lower central incisor at maximal mouth | 7days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impacted third molar, melatonine, bone healing