Controlling Post-extraction Complications of Impacted Mandibular Third Molar

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

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

Study Overview

• Status: Completed
• Conditions: Preventing Postextraction Complication
• Intervention / Treatment: Drug: Normal saline; Drug: Hyaluronic acid; Drug: Methylprednisolone; Drug: Methylprednisolone and Hyaluronic acid

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Vision college

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy patients
• patient has impacted 3rd molar

Exclusion Criteria:

• medically compromised patients Heavy smoking patients

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hyaluronic Acid
• Other Study ID Numbers: Extraction healing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No