NCT04816253

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

March 23, 2021

Last Update Submit

July 20, 2021

Conditions

Preventing Postextraction Complication

Outcome Measures

Primary Outcomes (19)

  • 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

Study Arms (4)

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Gengigel

ACTIVE COMPARATOR

Gengigel (Hyaluronic acid) placed after extraction

Drug: Hyaluronic acid

Methylprednisolone

ACTIVE COMPARATOR

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

Drug: Methylprednisolone

Methylprednisolone and Gengigel

ACTIVE COMPARATOR

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

Normal salineDRUG

Normal saline irrigation and No other drug placed after extraction

Normal saline
Hyaluronic acidDRUG

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

Also known as: Gengigel
Gengigel
MethylprednisoloneDRUG

Methylprednsolone will be injected half an hour preoperatively

Methylprednisolone
Methylprednisolone and Hyaluronic acidDRUG

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

Methylprednisolone and Gengigel

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy patients
  • patient has impacted 3rd molar

You may not qualify if:

  • medically compromised patients Heavy smoking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision college

Jeddah, Saudi Arabia

Location

MeSH Terms

Interventions

Saline SolutionHyaluronic AcidMethylprednisolone

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsGlycosaminoglycansPolysaccharidesCarbohydratesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

February 10, 2021

Primary Completion

June 20, 2021

Study Completion

June 20, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

SA(1)