Extraction Socket HealingNCT05911607
PBMT Influence on Alveolar Socket Preservation
A study testing Low power laser in people with Extraction Socket Healing, run by Cairo University at 1 site in Egypt.
Trial summary
Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Extraction Socket Healing
- What is being tested?
- Low power laser
- 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 Jul 2021to 15 Sep 2022
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fit for implant rehabilitation.
- Acceptable oral hygiene.
- Willingness to attend 6 visits within 15 days of extraction.
Who cannot join
- Uncontrolled diabetes.
- Sub optimal oral hygiene.
- Heavy smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Photobiomodulation Therapy (PBMT) as an Adjunctive Therapy in Alveolar Socket Preservation Preceding Dental Implant Placement
Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing.
Read the detailed description
After molar tooth extraction, 6 Low power (PBMT) laser sessions.
Evaluation:
Visual Radiographic Histological
- Conditions
- Extraction Socket Healing
- Being tested
- Low power laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low power laserProcedure or surgery
Phototherapy for extraction sockets using two different lasers.
| Study group | Role | What they receive |
|---|---|---|
| Red Laser | Active comparator | Photobiomodulation using nm Diode. Receives: Procedure: Low power laser |
| Infrared Laser | Active comparator | Photobiomodulation using nm Diode. Receives: Procedure: Low power laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic socket dimensions
Alveolar Socket surface area measured on Cone Beam Computerised Tomography
Measured: 3 months
Secondary outcomes (2)
Soft tissue healing
Landry, Turnbull, Howley healing index; scoring from 1 to 5 where 1 represents very poor healing while 5 denotes perfect healing.
Measured: 15 days
Histological examination
Histological examination of bone samples
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2021
- Primary completion1 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extraction Socket HealingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing between 2 laser' effect on extraction socket healing
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Anwar Abd-Elhaleem Othman, Cairo University
- Investigators
- Ahmed Ab Zaky, Study director, National Institute of Laser Enhanced Sciences, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911607
- Sponsor's protocol ID
- 2905561312919
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosero KAV, Sampaio RMF, Deboni MCZ, Correa L, Marques MM, Ferraz EP, da Graca Naclerio-Homem M. Photobiomodulation as an adjunctive therapy for alveolar socket preservation: a preliminary study in humans. Lasers Med Sci. 2020 Oct;35(8):1711-1720. doi: 10.1007/s10103-020-02962-y. Epub 2020 Jan 22.
PubMed 31970564
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Photobiomodulation Therapy (PBMT) as an Adjunctive Therapy in Alveolar Socket Preservation Preceding Dental Implant Placement
- ClinicalTrials.gov ID
- NCT05911607
- Acronym / sponsor ID
- 2905561312919
- Conditions
- Extraction Socket Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 22 Jun 2023 (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.
Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing.
Detailed description
After molar tooth extraction, 6 Low power (PBMT) laser sessions.
Evaluation:
Visual Radiographic Histological
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparing between 2 laser' effect on extraction socket healing
| Arm | Type | Receives |
|---|---|---|
| Red Laser | Active comparator | Procedure: Low power laserPhotobiomodulation using nm Diode. |
| Infrared Laser | Active comparator | Procedure: Low power laserPhotobiomodulation using nm Diode. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fit for implant rehabilitation.
- Acceptable oral hygiene.
- Willingness to attend 6 visits within 15 days of extraction.
Key exclusion criteria (3 listed)
- Uncontrolled diabetes.
- Sub optimal oral hygiene.
- Heavy smoker.
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 power laserPhototherapy for extraction sockets using two different lasers. | Procedure or surgery | Infrared Laser, Red Laser |
Primary outcome
Radiographic socket dimensions
Time frame: 3 months
Alveolar Socket surface area measured on Cone Beam Computerised Tomography
2 secondary outcomes
Soft tissue healing
Time frame: 15 days
Histological examination
Time frame: 3 months
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 Jun 2023.
- Background: PubMed 31970564Rosero KAV, Sampaio RMF, Deboni MCZ, Correa L, Marques MM, Ferraz EP, da Graca Naclerio-Homem M. Photobiomodulation as an adjunctive therapy for alveolar socket preservation: a preliminary study in humans. Lasers Med Sci. 2020 Oct;35(8):1711-1720. doi: 10.1007/s10103-020-02962-y. Epub 2020 Jan 22.
- Individual participant dataSharing planned: No
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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.
Ahmed Ab Zaky study director
National Institute of Laser Enhanced Sciences, Cairo 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 power laser in people with Extraction Socket Healing, run by Cairo 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 3 inclusion and 3 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 Jun 2023. 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?
Radiographic socket dimensions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911607, which also lists 1 linked publication.
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 Jun 2023.