Controlling Post-extraction Complications of Impacted Mandibular Third Molar

July 20, 2021 updated by: Alaa Altaweel, Al-Azhar University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Interincisal distance
Time Frame: Baseline (Preoperative)
Measuring distance between upper lower anterior teeth in mm
Baseline (Preoperative)
Interincisal distance
Time Frame: 1 day postoperative
Measuring distance between upper lower anterior teeth in mm
1 day postoperative
Interincisal distance
Time Frame: 2nd day postoperative
Measuring distance between upper lower anterior teeth in mm
2nd day postoperative
Interincisal distance
Time Frame: 3rd day postoperative
Measuring distance between upper lower anterior teeth in mm
3rd day postoperative
Interincisal distance
Time Frame: 7th day postoperative
Measuring distance between upper lower anterior teeth in mm
7th day postoperative
Assessment of pain using Visual analog scale
Time Frame: Baseline (Preoperative)
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
Time Frame: 1st day
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
Time Frame: 2nd day
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
Time Frame: 3rd day
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
Time Frame: 7th day
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
Time Frame: 1st day postoperative
Total amount of analgesic Will be calculated
1st day postoperative
Total amount of analgesic
Time Frame: 2nd day postoperative
Total amount of analgesic Will be calculated
2nd day postoperative
Total amount of analgesic
Time Frame: 3rd day postoperative
Total amount of analgesic Will be calculated
3rd day postoperative
Total amount of analgesic
Time Frame: 7th day postoperative
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
Time Frame: Baseline
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
Time Frame: 1st day postoperative
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
Time Frame: 2nd day postoperative
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
Time Frame: 3rd day postoperative
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
Time Frame: 7th day postoperative
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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