Socket SealingNCT06764732
Socket Seal Surgery
A study testing bioactive glass, bioactive glass graft and PBM irradiation and Platelet rich fibrin in people with Socket Sealing, run by Al-Azhar University at 1 site in Egypt.
Trial summary
laser photo biomodulation (PBM) as a supplement to socket seal surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Socket Sealing
- What is being tested?
- bioactive glass, bioactive glass graft and PBM irradiation and Platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 10 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least a periodontal-affected and non-restorable tooth in posterior region (Class II sockets).
- At least 10% plaque control scoring was accepted
- A moderate to thick gingival phenotype
Who cannot join
- systemic diseases or conditions that may compromise healing or bone metabolism,
- having a history of radiotherapy, chemotherapy or bisphosphonate therapy, previous use of antibiotics in the last 3
Trial locations and contacts
1 site in 1 country.
Egypt1 site
, Faculty of Oral and Dental Medicine, Delta University for Science and Technology (DU), Dakahlia, Egypt
Dakahlia
About this study
Official title: Laser Assisted Socket Seal Surgery Using Bioactive Glass for Dental Implant Site Development
laser photo biomodulation (PBM) as a supplement to socket seal surgery
Read the detailed description
the role of PBM therapy as an adjunct for bioactive glass graft in SSS approaches
- Conditions
- Socket Sealing
- Being tested
- bioactive glass, bioactive glass graft and PBM irradiation, Platelet rich fibrin
- Keywords
- bio active glass, socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioactive glassBiological
supplied as resorbable form, (400-800um) particle siz
bioactive glass graft and PBM irradiationRadiation
The used laser parameters were set as: wavelength, 980 nm; power, 0.55 W; energy, 36 J; power density, 0.76 W cm2
Platelet rich fibrinBiological
10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | platelet rich fibrin membrane Receives: Biological: Platelet rich fibrin |
| test 1 group | Experimental | bioactive glass Receives: Biological: bioactive glass; Biological: Platelet rich fibrin |
| test 2group | Active comparator | bioactive glass and Photobiomodulation Receives: Biological: bioactive glass; Radiation: bioactive glass graft and PBM irradiation; Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar ridge dimensional changes in height and width measures
Measured: at base line and after 9 months
Secondary outcomes (1)
bone biopsy
Measured: after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start10 Nov 2022
- Primary completion10 Nov 2023
- Study completion10 Feb 2024
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 Socket SealingStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Abdelgawad Mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764732
- Sponsor's protocol ID
- DU:024100558
- Status last verified
- Nov 2022
- First submitted
- 3 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hazzaa HH, Shiekh MAME, AbdAllah MF, Abdelgawad N, El-Mahdy MA, Shoshan HS, Elewa GM. Laser-assisted socket seal surgery using bioactive glass for dental implant site development: a randomized clinical trial. Sci Rep. 2025 Dec 9;15(1):43386. doi: 10.1038/s41598-025-28824-7.
PubMed 41360883
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Assisted Socket Seal Surgery Using Bioactive Glass for Dental Implant Site Development
- ClinicalTrials.gov ID
- NCT06764732
- Acronym / sponsor ID
- DU:024100558
- Conditions
- Socket Sealing
- Keywords
- bio active glass, socket preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 8 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.
laser photo biomodulation (PBM) as a supplement to socket seal surgery
Detailed description
the role of PBM therapy as an adjunct for bioactive glass graft in SSS approaches
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Biological: Platelet rich fibrinplatelet rich fibrin membrane |
| test 1 group | Experimental | Biological: bioactive glass, Biological: Platelet rich fibrinbioactive glass |
| test 2group | Active comparator | Biological: bioactive glass, Radiation: bioactive glass graft and PBM irradiation, Biological: Platelet rich fibrinbioactive glass and Photobiomodulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of at least a periodontal-affected and non-restorable tooth in posterior region (Class II sockets).
- At least 10% plaque control scoring was accepted
- A moderate to thick gingival phenotype
Key exclusion criteria (2 listed)
- systemic diseases or conditions that may compromise healing or bone metabolism,
- having a history of radiotherapy, chemotherapy or bisphosphonate therapy, previous use of antibiotics in the last 3
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 |
|---|---|---|
| bioactive glasssupplied as resorbable form, (400-800um) particle siz | Biological | test 1 group, test 2group |
| bioactive glass graft and PBM irradiationThe used laser parameters were set as: wavelength, 980 nm; power, 0.55 W; energy, 36 J; power density, 0.76 W cm2 | Radiation | test 2group |
| Platelet rich fibrin10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained | Biological | control group, test 1 group, test 2group |
Primary outcome
alveolar ridge dimensional changes in height and width measures
Time frame: at base line and after 9 months
1 secondary outcome
bone biopsy
Time frame: after 9 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 8 Jan 2025.
- Derived from this study: PubMed 41360883Hazzaa HH, Shiekh MAME, AbdAllah MF, Abdelgawad N, El-Mahdy MA, Shoshan HS, Elewa GM. Laser-assisted socket seal surgery using bioactive glass for dental implant site development: a randomized clinical trial. Sci Rep. 2025 Dec 9;15(1):43386. doi: 10.1038/s41598-025-28824-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 bioactive glass, bioactive glass graft and PBM irradiation and Platelet rich fibrin in people with Socket Sealing, run by Al-Azhar 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 2 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 8 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. 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?
alveolar ridge dimensional changes in height and width measures (time frame: at base line and after 9 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 NCT06764732, 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 8 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.