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CompletedNCT04816253Updated Jul 22, 2021

Controlling Post-extraction Complications of Impacted Mandibular Third Molar

An interventional study of Normal saline and Hyaluronic acid in Preventing Postextraction Complication, sponsored by Al-Azhar University. Completed at 1 site in Saudi Arabia. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Preventing Postextraction Complication

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03

In context

Tooth, Impacted

195 studies on the registry are indexed under Tooth, Impacted; 20 are open to participants now.

This study's enrollment of 72 is above the median of 53 across 164 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy patients
  • patient has impacted 3rd molar

Exclusion criteria

Exclusion Criteria:

  • medically compromised patients Heavy smoking patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Placebo comparator
    Normal saline

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

    Drug: Normal saline

  • Active comparator
    Gengigel

    Gengigel (Hyaluronic acid) placed after extraction

    Drug: Hyaluronic acid

  • Active comparator
    Methylprednisolone

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

    Drug: Methylprednisolone

  • 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

Interventions

  • DrugNormal saline

    Normal saline irrigation and No other drug placed after extraction

  • DrugHyaluronic acid

    Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket

    Also known as: Gengigel

  • DrugMethylprednisolone

    Methylprednsolone will be injected half an hour preoperatively

  • DrugMethylprednisolone and Hyaluronic acid

    Methylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket

06

What researchers measure

Primary outcomes

  1. Interincisal distance

    Measuring distance between upper lower anterior teeth in mm

    Time frame: Baseline (Preoperative)

  2. Interincisal distance

    Measuring distance between upper lower anterior teeth in mm

    Time frame: 1 day postoperative

  3. Interincisal distance

    Measuring distance between upper lower anterior teeth in mm

    Time frame: 2nd day postoperative

  4. Interincisal distance

    Measuring distance between upper lower anterior teeth in mm

    Time frame: 3rd day postoperative

  5. Interincisal distance

    Measuring distance between upper lower anterior teeth in mm

    Time frame: 7th day postoperative

  6. 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

    Time frame: Baseline (Preoperative)

  7. 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

    Time frame: 1st day

  8. 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

    Time frame: 2nd day

  9. 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

    Time frame: 3rd day

  10. 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

    Time frame: 7th day

  11. Total amount of analgesic

    Total amount of analgesic Will be calculated

    Time frame: 1st day postoperative

  12. Total amount of analgesic

    Total amount of analgesic Will be calculated

    Time frame: 2nd day postoperative

  13. Total amount of analgesic

    Total amount of analgesic Will be calculated

    Time frame: 3rd day postoperative

  14. Total amount of analgesic

    Total amount of analgesic Will be calculated

    Time frame: 7th day postoperative

  15. 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

    Time frame: Baseline

  16. 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

    Time frame: 1st day postoperative

  17. 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

    Time frame: 2nd day postoperative

  18. 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

    Time frame: 3rd day postoperative

  19. 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

    Time frame: 7th day postoperative

07

Study locations

1 site
  • Vision college
    Jeddah, Saudi Arabia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04816253
Lead sponsor
Al-Azhar University
Responsible party
Alaa Altaweel (Associate professor, Al-Azhar University) — Principal investigator
First posted
Mar 25, 2021
Start date
Feb 10, 2021
Primary completion
Jun 20, 2021
Completion
Jun 20, 2021
Last update
Jul 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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