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Controlling Post-extraction Complications of Impacted Mandibular Third Molar

Primary Purpose

Preventing Postextraction Complication

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Normal saline
Hyaluronic acid
Methylprednisolone
Methylprednisolone and Hyaluronic acid
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preventing Postextraction Complication

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy patients
  • patient has impacted 3rd molar

Exclusion Criteria:

  • medically compromised patients Heavy smoking patients

Sites / Locations

  • Vision college

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Normal saline

Gengigel

Methylprednisolone

Methylprednisolone and Gengigel

Arm Description

Normal saline irrigation after extraction and No drug placed in tooth socket

Gengigel (Hyaluronic acid) placed after extraction

Methylprednisolone will be given intravenous to a patient half an hour before the surgery

Methylprednisolone will be given intravenous to a patient half an hour before the surgery and Gengigel (Hyaluronic acid) placed after extraction

Outcomes

Primary Outcome Measures

Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
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
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
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
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
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
Total amount of analgesic
Total amount of analgesic Will be calculated
Total amount of analgesic
Total amount of analgesic Will be calculated
Total amount of analgesic
Total amount of analgesic Will be calculated
Total amount of analgesic
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
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
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
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
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
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
July 20, 2021
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04816253
Brief Title
Controlling Post-extraction Complications of Impacted Mandibular Third Molar
Official Title
Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventing Postextraction Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline irrigation after extraction and No drug placed in tooth socket
Arm Title
Gengigel
Arm Type
Active Comparator
Arm Description
Gengigel (Hyaluronic acid) placed after extraction
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Methylprednisolone will be given intravenous to a patient half an hour before the surgery
Arm Title
Methylprednisolone and Gengigel
Arm Type
Active Comparator
Arm Description
Methylprednisolone will be given intravenous to a patient half an hour before the surgery and Gengigel (Hyaluronic acid) placed after extraction
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline irrigation and No other drug placed after extraction
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Other Intervention Name(s)
Gengigel
Intervention Description
Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednsolone will be injected half an hour preoperatively
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone and Hyaluronic acid
Intervention Description
Methylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
Primary Outcome Measure Information:
Title
Interincisal distance
Description
Measuring distance between upper lower anterior teeth in mm
Time Frame
Baseline (Preoperative)
Title
Interincisal distance
Description
Measuring distance between upper lower anterior teeth in mm
Time Frame
1 day postoperative
Title
Interincisal distance
Description
Measuring distance between upper lower anterior teeth in mm
Time Frame
2nd day postoperative
Title
Interincisal distance
Description
Measuring distance between upper lower anterior teeth in mm
Time Frame
3rd day postoperative
Title
Interincisal distance
Description
Measuring distance between upper lower anterior teeth in mm
Time Frame
7th day postoperative
Title
Assessment of pain using Visual analog scale
Description
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
Time Frame
Baseline (Preoperative)
Title
Assessment of pain using Visual analog scale
Description
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
Time Frame
1st day
Title
Assessment of pain using Visual analog scale
Description
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
Time Frame
2nd day
Title
Assessment of pain using Visual analog scale
Description
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
Time Frame
3rd day
Title
Assessment of pain using Visual analog scale
Description
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
Time Frame
7th day
Title
Total amount of analgesic
Description
Total amount of analgesic Will be calculated
Time Frame
1st day postoperative
Title
Total amount of analgesic
Description
Total amount of analgesic Will be calculated
Time Frame
2nd day postoperative
Title
Total amount of analgesic
Description
Total amount of analgesic Will be calculated
Time Frame
3rd day postoperative
Title
Total amount of analgesic
Description
Total amount of analgesic Will be calculated
Time Frame
7th day postoperative
Title
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Description
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
Time Frame
Baseline
Title
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Description
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
Time Frame
1st day postoperative
Title
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Description
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
Time Frame
2nd day postoperative
Title
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Description
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
Time Frame
3rd day postoperative
Title
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Description
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
Time Frame
7th day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy patients patient has impacted 3rd molar Exclusion Criteria: medically compromised patients Heavy smoking patients
Facility Information:
Facility Name
Vision college
City
Jeddah
Country
Saudi Arabia

12. IPD Sharing Statement

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Controlling Post-extraction Complications of Impacted Mandibular Third Molar

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