Controlling Post-extraction Complications of Impacted Mandibular Third Molar

Preventing Postextraction Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816253
• Other study ID #: Extraction healing
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: June 20, 2021

Study information

• Verified date: July 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy patients

• patient has impacted 3rd molar

Exclusion Criteria:

• medically compromised patients Heavy smoking patients

Related Conditions & MeSH terms

• Preventing Postextraction Complication
• Tooth, Impacted

Intervention

Drug:
• Normal saline
Normal saline irrigation and No other drug placed after extraction
• Hyaluronic acid
Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
• Methylprednisolone
Methylprednsolone will be injected half an hour preoperatively
• 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

Locations

Country	Name	City	State
Saudi Arabia	Vision college	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interincisal distance	Measuring distance between upper lower anterior teeth in mm	Baseline (Preoperative)
Primary	Interincisal distance	Measuring distance between upper lower anterior teeth in mm	1 day postoperative
Primary	Interincisal distance	Measuring distance between upper lower anterior teeth in mm	2nd day postoperative
Primary	Interincisal distance	Measuring distance between upper lower anterior teeth in mm	3rd day postoperative
Primary	Interincisal distance	Measuring distance between upper lower anterior teeth in mm	7th day postoperative
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Total amount of analgesic	Total amount of analgesic Will be calculated	1st day postoperative
Primary	Total amount of analgesic	Total amount of analgesic Will be calculated	2nd day postoperative
Primary	Total amount of analgesic	Total amount of analgesic Will be calculated	3rd day postoperative
Primary	Total amount of analgesic	Total amount of analgesic Will be calculated	7th day postoperative
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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