Maxillary CystNCT06759571
Impact of Photobiomodulation Bone Healing Following Cystic Enucleation
A study testing low level laser treatment in people with Maxillary Cyst, run by Minia University at 1 site in Egypt.
Trial summary
A well-known issues confronted by oral and maxillofacial specialists are the osseous defects and dead spaces and how can be obliterated and augmented in the facial regions. Unerupted tooth and bone loss after its removal, remaining roots and enucleation of cysts; all of which makes prosthetic rehabilitation and… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Maxillary Cyst
- What is being tested?
- low level laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 10 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients (class I category according to American society of anesthesiologists) over 20 years and under 50 years of age, of either gender who are seeking cyst enucleation of painful intra-body maxillary cystic lesions 3 x 4 cm in size.
Who cannot join
- any systemic disease that interferes with bone healing,
- patients with significant medical condition,
- alcoholic individuals,
- patients on drugs that affect the central nervous systems,
- patients who reported the use of drugs that might interfere with pain sensitivity
- pregnancy,
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Photobiomodulation Bone Healing Following Cystic Enucleation: A Randomized Clinical Trial
A well-known issues confronted by oral and maxillofacial specialists are the osseous defects and dead spaces and how can be obliterated and augmented in the facial regions. Unerupted tooth and bone loss after its removal, remaining roots and enucleation of cysts; all of which makes prosthetic rehabilitation and implant application more complicated
Read the detailed description
Bone is undergoes remodeling via cycles of bone resorption and bone formation which is considered a mineralized connective tissue, an inflammatory immune reaction which is triggered by local injury which is thought to highly influence the outcome of the bone healing process.
Low-Level Laser Therapy (LLLT) is a form of phototherapy that involves the application of low power monochromatic and coherent light to areas of injuries and lesions. It has been shown to induce wound healing in non-healing bone defects .
Bone healing is a multidimensional process of reconstruction of the bone tissue with an overlapping timeline. Because of the regeneration ability of the bone, bone defects can heal spontaneously under suitable physiological environmental conditions. The healing process of the bone defect is time consuming, and new bone generation takes place slowly because of diminished of blood supply to the defect site and insufficiency of calcium and phosphorus to strengthen and harden new bone.
The low-level laser therapy (LLLT) has a positive effect on bone tissue metabolism . Moreover it is beneficial for the initial stages of alveolar bone healing and for further calcification; An experimental animal study in both diabetic and normal rats under histological observations and gene expression analyses have confirmed this when applied at a dose of 13.95 J/cm2 for 60 sec .
- Conditions
- Maxillary Cyst
- Being tested
- low level laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser treatmentProcedure or surgery
Also called Maxillary cystic enucleation
to evaluate the effect of low-level laser therapy (LLLT) bone healing when used prior and following enucleation of intra-body maxillary cystic lesions
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 10 patients who will be subjected to low intensity diode laser "soft-laser SL202" ("PERTO LASER", pr. Stachek, 47, Saint Petersburg, Russia) before surgery (two times / week for two weeks) and then following surgery (for three times per week for four weeks). Receives: Procedure: low level laser treatment |
| Group B | Active comparator | About 10 patients who will undergo conventional surgical enucleation of intra-body maxillary cystic lesions. Receives: Procedure: low level laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post- operative pain assessment
Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced.(record will be every 24h for 7 days)
Measured: From First 24 hours after The procedure till 7 days
Secondary outcomes (1)
Radiographic assessment
CBCT (Planmeca. Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative, 3 and 6 months postoperative.
Measured: From baseline to 3 and 6 months after the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2024
- Primary completion1 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary CystStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Abdelbarry, Minia University
- Investigators
- TAREK ABDELBARY, Lecturer, Principal investigator, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759571
- Sponsor's protocol ID
- Photobiomodulation
- Status last verified
- Feb 2024
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Photobiomodulation Bone Healing Following Cystic Enucleation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06759571
- Acronym / sponsor ID
- Photobiomodulation
- Conditions
- Maxillary Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 6 Jan 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.
A well-known issues confronted by oral and maxillofacial specialists are the osseous defects and dead spaces and how can be obliterated and augmented in the facial regions. Unerupted tooth and bone loss after its removal, remaining roots and enucleation of cysts; all of which makes prosthetic rehabilitation and implant application more complicated
Detailed description
Bone is undergoes remodeling via cycles of bone resorption and bone formation which is considered a mineralized connective tissue, an inflammatory immune reaction which is triggered by local injury which is thought to highly influence the outcome of the bone healing process.
Low-Level Laser Therapy (LLLT) is a form of phototherapy that involves the application of low power monochromatic and coherent light to areas of injuries and lesions. It has been shown to induce wound healing in non-healing bone defects .
Bone healing is a multidimensional process of reconstruction of the bone tissue with an overlapping timeline. Because of the regeneration ability of the bone, bone defects can heal spontaneously under suitable physiological environmental conditions. The healing process of the bone defect is time consuming, and new bone generation takes place slowly because of diminished of blood supply to the defect site and insufficiency of calcium and phosphorus to strengthen and harden new bone.
The low-level laser therapy (LLLT) has a positive effect on bone tissue metabolism . Moreover it is beneficial for the initial stages of alveolar bone healing and for further calcification; An experimental animal study in both diabetic and normal rats under histological observations and gene expression analyses have confirmed this when applied at a dose of 13.95 J/cm2 for 60 sec .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: low level laser treatmentAbout 10 patients who will be subjected to low intensity diode laser "soft-laser SL202" ("PERTO LASER", pr. Stachek, 47, Saint Petersburg, Russia) before surgery (two times / week for two weeks) and then following surgery (for three times per week for four weeks). |
| Group B | Active comparator | Procedure: low level laser treatmentAbout 10 patients who will undergo conventional surgical enucleation of intra-body maxillary cystic lesions. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients (class I category according to American society of anesthesiologists) over 20 years and under 50 years of age, of either gender who are seeking cyst enucleation of painful intra-body maxillary cystic lesions 3 x 4 cm in size.
Key exclusion criteria (7 listed)
- any systemic disease that interferes with bone healing,
- patients with significant medical condition,
- alcoholic individuals,
- patients on drugs that affect the central nervous systems,
- patients who reported the use of drugs that might interfere with pain sensitivity
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 |
|---|---|---|
| low level laser treatmentAlso: Maxillary cystic enucleationto evaluate the effect of low-level laser therapy (LLLT) bone healing when used prior and following enucleation of intra-body maxillary cystic lesions | Procedure or surgery | Group A, Group B |
Primary outcome
Post- operative pain assessment
Time frame: From First 24 hours after The procedure till 7 days
Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced.(record will be every 24h for 7 days)
1 secondary outcome
Radiographic assessment
Time frame: From baseline to 3 and 6 months after the operation day
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 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Maxillary Cyst
Recruiting
Artificial Intelligence-Based Assessment of Endosseous Lesions
Maxillary Cyst, Mandibular Cyst
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.
TAREK ABDELBARY, Lecturer principal investigator
Faculty of Dentistry, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser treatment in people with Maxillary Cyst, run by Minia 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 1 inclusion and 7 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 6 Jan 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?
Post- operative pain assessment (time frame: From First 24 hours after The procedure till 7 days). 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 6 Jan 2025.