Preventing Postextraction ComplicationNCT04816253
Controlling Post-extraction Complications of Impacted Mandibular Third Molar
A study testing Normal saline, Hyaluronic acid and Methylprednisolone in people with Preventing Postextraction Complication, run by Al-Azhar University at 1 site in Saudi Arabia.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Preventing Postextraction Complication
- What is being tested?
- Normal saline, Hyaluronic acid and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Feb 2021to 20 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy patients
- patient has impacted 3rd molar
Who cannot join
- medically compromised patients Heavy smoking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Preventing Postextraction Complication
- Being tested
- Normal saline, Hyaluronic acid, Methylprednisolone, Methylprednisolone and Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Normal saline irrigation and No other drug placed after extraction
Hyaluronic acidDrug
Also called Gengigel
Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
Methylprednsolone will be injected half an hour preoperatively
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
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Normal saline irrigation after extraction and No drug placed in tooth socket Receives: Drug: Normal saline |
| Gengigel | Active comparator | Gengigel (Hyaluronic acid) placed after extraction Receives: Drug: Hyaluronic acid |
| Methylprednisolone | Active comparator | Methylprednisolone will be given intravenous to a patient half an hour before the surgery Receives: 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 Receives: Drug: Methylprednisolone and Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Measured: Baseline (Preoperative)
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Measured: 1 day postoperative
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Measured: 2nd day postoperative
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Measured: 3rd day postoperative
Interincisal distance
Measuring distance between upper lower anterior teeth in mm
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7th day
Total amount of analgesic
Total amount of analgesic Will be calculated
Measured: 1st day postoperative
Total amount of analgesic
Total amount of analgesic Will be calculated
Measured: 2nd day postoperative
Total amount of analgesic
Total amount of analgesic Will be calculated
Measured: 3rd day postoperative
Total amount of analgesic
Total amount of analgesic Will be calculated
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7th day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start10 Feb 2021
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventing Postextraction ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Altaweel, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816253
- Sponsor's protocol ID
- Extraction healing
- Status last verified
- Jul 2021
- First submitted
- 23 Mar 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar
- ClinicalTrials.gov ID
- NCT04816253
- Acronym / sponsor ID
- Extraction healing
- Conditions
- Preventing Postextraction Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline irrigation after extraction and No drug placed in tooth socket |
| Gengigel | Active comparator | Drug: Hyaluronic acidGengigel (Hyaluronic acid) placed after extraction |
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneMethylprednisolone will be given intravenous to a patient half an hour before the surgery |
| Methylprednisolone and Gengigel | Active comparator | Drug: Methylprednisolone and Hyaluronic acidMethylprednisolone will be given intravenous to a patient half an hour before the surgery and Gengigel (Hyaluronic acid) placed after extraction |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy patients
- patient has impacted 3rd molar
Key exclusion criteria (1 listed)
- medically compromised patients Heavy smoking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineNormal saline irrigation and No other drug placed after extraction | Drug | Normal saline |
| Hyaluronic acidAlso: GengigelImmediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket | Drug | Gengigel |
| MethylprednisoloneMethylprednsolone will be injected half an hour preoperatively | Drug | Methylprednisolone |
| Methylprednisolone and Hyaluronic acidMethylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket | Drug | Methylprednisolone and Gengigel |
Primary outcome
Interincisal distance
Time frame: Baseline (Preoperative)
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Time frame: 1 day postoperative
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Time frame: 2nd day postoperative
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Time frame: 3rd day postoperative
Measuring distance between upper lower anterior teeth in mm
Interincisal distance
Time frame: 7th day postoperative
Measuring distance between upper lower anterior teeth in mm
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
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
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
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
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
Total amount of analgesic
Time frame: 1st day postoperative
Total amount of analgesic Will be calculated
Total amount of analgesic
Time frame: 2nd day postoperative
Total amount of analgesic Will be calculated
Total amount of analgesic
Time frame: 3rd day postoperative
Total amount of analgesic Will be calculated
Total amount of analgesic
Time frame: 7th day postoperative
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
Time frame: Baseline
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline, Hyaluronic acid and Methylprednisolone in people with Preventing Postextraction Complication, run by Al-Azhar University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interincisal distance (time frame: Baseline (Preoperative)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.