Controlling Post-extraction Complications of Impacted Mandibular Third Molar

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT04816253

Collaborator

(none)

Enrollment

Location

Arms

4.3

Actual Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preventing Postextraction Complication	Drug: Normal saline Drug: Hyaluronic acid Drug: Methylprednisolone Drug: Methylprednisolone and Hyaluronic acid	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 10, 2021

Actual Primary Completion Date :

Jun 20, 2021

Actual Study Completion Date :

Jun 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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