Alveolar OsteitisNCT06865508
Photo Biomodulation Therapy for Alveolar Osteitis Recovery in Oral Contraceptive Users
A study testing Laser therapy and zinc oxide eugenol dressing. in people with Alveolar Osteitis, run by Badr University at 1 site in Egypt.
Trial summary
does laser effect on alveolar osteitis recovery in oral contraceptive users ? Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Laser therapy and zinc oxide eugenol dressing.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Dec 2024
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 25-40 years. Currently using oral contraceptives for at least 3 months prior to participation.
- Diagnosed with dry socket (alveolar osteitis) based on clinical criteria.
Who cannot join
- Presence of systemic diseases (e.g., diabetes, immunodeficiency disorders). Smoking or tobacco use. Allergies to zinc oxide or other study materials. Use of antibiotics or anti-inflammatory medications within the last 2 weeks. Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
does laser effect on alveolar osteitis recovery in oral contraceptive users ?
Read the detailed description
photo biomodulation therapy for alveolar osteitis recovery in oral contraceptive users
- Conditions
- Alveolar Osteitis
- Being tested
- Laser therapy, zinc oxide eugenol dressing.
- Keywords
- alveolar osteitis and oral contraceptive
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyDevice
Laser therapy was administered using a low-level laser device with the following parameters: [ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides].
zinc oxide eugenol dressing.Device
zinc oxide eugenol dressing.
| Study group | Role | What they receive |
|---|---|---|
| 1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing. | Experimental | * Laser therapy was administered using a low-level laser device with the following parameters: [ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides].
* Zinc oxide eugenol dressing was applied immediately before the laser therapy.
* The intervention will be performed at [specified intervals every day 0, day7, day 14, day 30)] Receives: Device: Laser therapy; Device: zinc oxide eugenol dressing. |
| control group | Active comparator | zinc oxide eugenol dressing. Receives: Device: zinc oxide eugenol dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity by VAS
Pain intensity measured using a Visual Analog Scale (VAS) at day0, day7, day14 post-treatment.
Measured: 4 weeks
Socket volume .
measured using [specific measurement technique, volumetric analysis] at day0, day14 and 1-month post-treatment
Measured: 4 weeks
Secondary outcomes (1)
Quality of life assessed
Quality of life assessed using the Oral Health Impact Profile (OHIP-5) questionnaire at day0, day7and day14 post-treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Nov 2023
- Primary completion1 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies 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
- Model description
- This study is a randomized clinical trial (RCT) designed to evaluate the effectiveness of laser therapy combined with zinc oxide eugenol dressing in comparison to zinc oxide eugenol dressing alone in the management of dry socket among females using oral contraceptives. The study assessed outcomes related to pain, quality of life, and socket volume.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Saeed Mohamed, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865508
- Sponsor's protocol ID
- BUC-IACUC-231015-38
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photo Biomodulation Therapy for Alveolar Osteitis Recovery in Oral Contraceptive Users
- ClinicalTrials.gov ID
- NCT06865508
- Acronym / sponsor ID
- BUC-IACUC-231015-38
- Conditions
- Alveolar Osteitis
- Keywords
- alveolar osteitis and oral contraceptive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 10 Mar 2025 (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.
does laser effect on alveolar osteitis recovery in oral contraceptive users ?
Detailed description
photo biomodulation therapy for alveolar osteitis recovery in oral contraceptive users
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized clinical trial (RCT) designed to evaluate the effectiveness of laser therapy combined with zinc oxide eugenol dressing in comparison to zinc oxide eugenol dressing alone in the management of dry socket among females using oral contraceptives. The study assessed outcomes related to pain, quality of life, and socket volume.
| Arm | Type | Receives |
|---|---|---|
| 1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing. | Experimental | Device: Laser therapy, Device: zinc oxide eugenol dressing.* Laser therapy was administered using a low-level laser device with the following parameters: [ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides]. * Zinc oxide eugenol dressing was applied immediately before the laser therapy. * The intervention will be performed at [specified intervals every day 0, day7, day 14, day 30)] |
| control group | Active comparator | Device: zinc oxide eugenol dressing.zinc oxide eugenol dressing. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patients aged 25-40 years. Currently using oral contraceptives for at least 3 months prior to participation.
- Diagnosed with dry socket (alveolar osteitis) based on clinical criteria.
Key exclusion criteria (1 listed)
- Presence of systemic diseases (e.g., diabetes, immunodeficiency disorders). Smoking or tobacco use. Allergies to zinc oxide or other study materials. Use of antibiotics or anti-inflammatory medications within the last 2 weeks. Pregnancy or breastfeeding.
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 |
|---|---|---|
| Laser therapyLaser therapy was administered using a low-level laser device with the following parameters: [ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides]. | Device | 1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing. |
| zinc oxide eugenol dressing.zinc oxide eugenol dressing. | Device | 1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing., control group |
Primary outcome
pain intensity by VAS
Time frame: 4 weeks
Pain intensity measured using a Visual Analog Scale (VAS) at day0, day7, day14 post-treatment.
Socket volume .
Time frame: 4 weeks
measured using [specific measurement technique, volumetric analysis] at day0, day14 and 1-month post-treatment
1 secondary outcome
Quality of life assessed
Time frame: 4 weeks
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 10 Mar 2025.
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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 Laser therapy and zinc oxide eugenol dressing. in people with Alveolar Osteitis, run by Badr University 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 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 10 Mar 2025. 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?
pain intensity by VAS (time frame: 4 weeks). The study lists 2 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 10 Mar 2025.