Tooth, ImpactedNCT04718077
Intraosseous vs Submucosal Injection of Dexamethasone
A study testing Intraosseus and Submucoal in people with Tooth, Impacted, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by one surgeon. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- Intraosseus and Submucoal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 30 Dec 2020
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the Pell and Gregory classification 1933)
- Healthy patient (American society of anesthesiologists class I status)
- Patient age range from 18 to 40 years old.
- Patient without any local inflammation or pathology.
- Patient who will able to understand verbal and written instructions.
Who cannot join
- Pregnant or breast-feeding women.
- Patient had anti-inflammatory drugs within 2 weeks before the procedure.
- Patient under radiotherapy or chemotherapy.
- Habits (heavy smoking and alcoholic).
- Allergy to drugs used in this study.
- Patient under anticoagulant or corticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)
Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by one surgeon.
Postoperative pain was evaluated by visual analog scale score immediately after surgery and on postoperative days 1, 3, and 7.
Read more
Swelling (determined using two linear measurements) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.
Early healing of periodontal soft tissue wound was assessed by using Early Wound Healing Score (EHS) which composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI) and were assessed on postoperative days 1, 7, and 14. Mouth opening (determined by measurement of the maximum inter-incisal distance) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.
- Conditions
- Tooth, Impacted
- Being tested
- Intraosseus, Submucoal
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraosseusOther
IO dexamethasone injection Dexamethasone 4 mg
SubmucoalOther
SM dexamethasone injection Dexamethasone 4 mg
| Study group | Role | What they receive |
|---|---|---|
| IO dexamethasone injection | Experimental | Not described Receives: Other: Intraosseus |
| SM dexamethasone injection. | Active comparator | Not described Receives: Other: Submucoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mouth opening
determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
Measured: baseline, 1st, 3rd, 7th days
change in swelling
assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper
- Horizontal reference between the corner of the mouth and the tragus of the ear.
- Vertical reference between the lateral canthus and the angle of the mandible.
Measured: 1st, 3rd, 14th days
change in pain scores
Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.
Measured: 1st, 3rd, 7th days
Secondary outcomes (1)
change in early healing of periodontal soft tissue wound
The EHS is composed of 3 parameters:
- Clinical signs of re-epithelization (CSR).
- Clinical signs of haemostasis (CSH).
- Clinical signs of inflammation (CSI).
Measured: 1st, 7th, 14th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Aug 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718077
- Sponsor's protocol ID
- Corticosteriod
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 22 Jan 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 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04718077
- Acronym / sponsor ID
- Corticosteriod
- Conditions
- Tooth, Impacted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 22 Jan 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.
Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by one surgeon.
Postoperative pain was evaluated by visual analog scale score immediately after surgery and on postoperative days 1, 3, and 7.
Swelling (determined using two linear measurements) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.
Early healing of periodontal soft tissue wound was assessed by using Early Wound Healing Score (EHS) which composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI) and were assessed on postoperative days 1, 7, and 14. Mouth opening (determined by measurement of the maximum inter-incisal distance) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IO dexamethasone injection | Experimental | Other: Intraosseus |
| SM dexamethasone injection. | Active comparator | Other: Submucoal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the Pell and Gregory classification 1933)
- Healthy patient (American society of anesthesiologists class I status)
- Patient age range from 18 to 40 years old.
- Patient without any local inflammation or pathology.
- Patient who will able to understand verbal and written instructions.
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women.
- Patient had anti-inflammatory drugs within 2 weeks before the procedure.
- Patient under radiotherapy or chemotherapy.
- Habits (heavy smoking and alcoholic).
- Allergy to drugs used in this study.
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 |
|---|---|---|
| IntraosseusIO dexamethasone injection Dexamethasone 4 mg | Other | IO dexamethasone injection |
| SubmucoalSM dexamethasone injection Dexamethasone 4 mg | Other | SM dexamethasone injection. |
Primary outcome
Change in mouth opening
Time frame: baseline, 1st, 3rd, 7th days
determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
change in swelling
Time frame: 1st, 3rd, 14th days
assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper 1. Horizontal reference between the corner of the mouth and the tragus of the ear. 2. Vertical reference between the lateral canthus and the angle of the mandible.
change in pain scores
Time frame: 1st, 3rd, 7th days
Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.
1 secondary outcome
change in early healing of periodontal soft tissue wound
Time frame: 1st, 7th, 14th days
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 Jan 2021.
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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 Intraosseus and Submucoal in people with Tooth, Impacted, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 5 inclusion and 6 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 Jan 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 Egypt. 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. 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?
Change in mouth opening (time frame: baseline, 1st, 3rd, 7th days). The study lists 3 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 Jan 2021.