Controlling Post-extraction Complications of Impacted Mandibular Third Molar

Study Overview
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Brief Summary
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Impacted mandibular 3rd molar will be extracted in all patients, then patients will be divided, according to material placed in extraction socket into 3 groups: control, hyaluronic acid and honey. Then post extraction complications will be evaluated

Detailed Description
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Impacted Mandibular third molar will be extracted under local anesthesia Through standard surgical flap elevation, after extraction and wound irrigation a material facilitate healing will be placed. According to material will be placed patients will be divide into 3 group: control ( no material, second group hyaluronic acid, third group ( honey).. then wound will be closed. Postoperative pain ( through visual analog scale) , edema, total dose of analgesic, mandibular movement (interincisal distance in mm) will be evaluated preoperative, 1,2,3,7, and 10 day after extraction

Official Title
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Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar

Conditions
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Preventing Postextraction Complication

Intervention / Treatment
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* Drug: Normal saline
* Drug: Hyaluronic acid
* Drug: Methylprednisolone
* Drug: Methylprednisolone and Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy patients patient has impacted 3rd molar Exclusion Criteria: medically compromised patients Heavy smoking patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline<br>Normal saline irrigation after extraction and No drug placed in tooth socket | Drug: Normal saline<br>* Normal saline irrigation and No other drug placed after extraction<br>|
| Active Comparator: Gengigel<br>Gengigel (Hyaluronic acid) placed after extraction | Drug: Hyaluronic acid<br>* Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket<br>* Other names: Gengigel;|
| Active Comparator: Methylprednisolone<br>Methylprednisolone will be given intravenous to a patient half an hour before the surgery | Drug: Methylprednisolone<br>* Methylprednsolone will be injected half an hour preoperatively<br>|
| Active Comparator: Methylprednisolone and Gengigel<br>Methylprednisolone will be given intravenous to a patient half an hour before the surgery and Gengigel (Hyaluronic acid) placed after extraction | Drug: Methylprednisolone and Hyaluronic acid<br>* Methylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interincisal distance | Measuring distance between upper lower anterior teeth in mm | Baseline (Preoperative) | 
| Interincisal distance | Measuring distance between upper lower anterior teeth in mm | 1 day postoperative | 
| Interincisal distance | Measuring distance between upper lower anterior teeth in mm | 2nd day postoperative | 
| Interincisal distance | Measuring distance between upper lower anterior teeth in mm | 3rd day postoperative | 
| Interincisal distance | Measuring distance between upper lower anterior teeth in mm | 7th day postoperative | 
| Assessment of pain using Visual analog scale | Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain | Baseline (Preoperative) | 
| Assessment of pain using Visual analog scale | Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain | 1st day | 
| Assessment of pain using Visual analog scale | Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain | 2nd day | 
| Assessment of pain using Visual analog scale | Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain | 3rd day | 
| Assessment of pain using Visual analog scale | Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain | 7th day | 
| Total amount of analgesic | Total amount of analgesic Will be calculated | 1st day postoperative | 
| Total amount of analgesic | Total amount of analgesic Will be calculated | 2nd day postoperative | 
| Total amount of analgesic | Total amount of analgesic Will be calculated | 3rd day postoperative | 
| Total amount of analgesic | Total amount of analgesic Will be calculated | 7th day postoperative | 
| Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle | Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively | Baseline | 
| Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle | Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively | 1st day postoperative | 
| Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle | Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively | 2nd day postoperative | 
| Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle | Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively | 3rd day postoperative | 
| Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle | Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively | 7th day postoperative |