Periodontal DiseasesPhase 3NCT06756854
Low-Level Laser Therapy and Injectable Platelet-Rich Fibrin for Thin Gingival Phenotype.
A Phase 3 study testing Biologic Agent: injectable platelet rich fibrin. and injecable platelet rich fibrin, and low level laser therapy radiation. in people with Periodontal Diseases, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Management of thin gingival phenotype using non-surgical methods (injection of liquid platelet rich fibrin and exposure to low level laser therapy Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Biologic Agent: injectable platelet rich fibrin. and injecable platelet rich fibrin, and low level laser therapy radiation.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2023to 15 Jun 2024
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- free systimatically good oral hygiene gingival thickness less than 1mm
Who cannot join
- pregnancy or lactation pereiodontitis periodontal surgery orthodontic ttt tooth mobility,bruxism,crowding,missing or supernumerary teeth smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Low-Level Laser Therapy as Adjunctive to the Injectable Platelet-Rich Fibrin in the Management of Patients With Thin Gingival Phenotype.
Management of thin gingival phenotype using non-surgical methods (injection of liquid platelet rich fibrin and exposure to low level laser therapy
Read the detailed description
Thin gingival phenotype can lead to recession and root exposure. Liquid prf can be obtained by centrifugion of blood sample on speed 700 rpm for 3 min, then injection of this liquid in the attached gingiva and muco-gingival junction (3 times with 7 days interval) for the first group. The second group will be injected with I-PRF in the same method in addition to exposure to Low Level Laser therapy (after each injection of I-PRF). This method is expected to increase the thickness of the gingiva.
- Conditions
- Periodontal Diseases
- Being tested
- Biologic Agent: injectable platelet rich fibrin., injecable platelet rich fibrin, and low level laser therapy radiation.
- Keywords
- I-PRF, thin gingival phenotype low level laser
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic Agent: injectable platelet rich fibrin.Biological
Also called Liquid platelet rich fibrin
injection of I-PRF to thin gingival phenotype 3 times with 7 days interval between sessions.
injecable platelet rich fibrin, and low level laser therapy radiation.Other
injection of I-PRF+ exposure to LLLT to thin gingival phenotype 3 times with 7 days interval between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Test group: injectable platelet rich fibrin+ low level laser therapy | Active comparator | patients with thin gingival phenotype (gingival thickness less than 1mm) recieve I-PRF+LLLT radiation just after the injection for 3 sessions with 7 days interval between the sessions. Receives: Other: injecable platelet rich fibrin, and low level laser therapy radiation. |
| Control group :I-PRF group | Active comparator | patients with thin gingival phenotype received I-PRF alone in 3 sessions, with 7 days interval between the sessions. Receives: Biological: Biologic Agent: injectable platelet rich fibrin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness improvement in millimeters.
clinical parameter
Measured: 6 months after treatment
Keratinized tissue width improvement in millimeters.
Clinincal parameter.
Measured: 6 months after treatment
Secondary outcomes (3)
Improvement of gingival index.
Clinical parameter.
Measured: 6 months after treatment
Improvement of bleeding on probing.
Clinical parameter.
Measured: 6 months after treatment
Improvement of sulcus depth.
Clinical parameter.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start12 Sep 2023
- Primary completion14 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group1: received I-PRF alone, and group 2: received I-PRF+LLLT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alaa Elsayed, Faculty of Dental Medicine for Girls
- Investigators
- Ahmed Eldawy, doctor, Principal investigator, MINDRAY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756854
- Sponsor's protocol ID
- P-ME-23-05
- Status last verified
- Dec 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Level Laser Therapy as Adjunctive to the Injectable Platelet-Rich Fibrin in the Management of Patients With Thin Gingival Phenotype.
- ClinicalTrials.gov ID
- NCT06756854
- Acronym / sponsor ID
- P-ME-23-05
- Conditions
- Periodontal Diseases
- Keywords
- I-PRF, thin gingival phenotype low level laser
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 3 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.
Management of thin gingival phenotype using non-surgical methods (injection of liquid platelet rich fibrin and exposure to low level laser therapy
Detailed description
Thin gingival phenotype can lead to recession and root exposure. Liquid prf can be obtained by centrifugion of blood sample on speed 700 rpm for 3 min, then injection of this liquid in the attached gingiva and muco-gingival junction (3 times with 7 days interval) for the first group. The second group will be injected with I-PRF in the same method in addition to exposure to Low Level Laser therapy (after each injection of I-PRF). This method is expected to increase the thickness of the gingiva.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group1: received I-PRF alone, and group 2: received I-PRF+LLLT
| Arm | Type | Receives |
|---|---|---|
| Test group: injectable platelet rich fibrin+ low level laser therapy | Active comparator | Other: injecable platelet rich fibrin, and low level laser therapy radiation.patients with thin gingival phenotype (gingival thickness less than 1mm) recieve I-PRF+LLLT radiation just after the injection for 3 sessions with 7 days interval between the sessions. |
| Control group :I-PRF group | Active comparator | Biological: Biologic Agent: injectable platelet rich fibrin.patients with thin gingival phenotype received I-PRF alone in 3 sessions, with 7 days interval between the sessions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- free systimatically good oral hygiene gingival thickness less than 1mm
Key exclusion criteria (1 listed)
- pregnancy or lactation pereiodontitis periodontal surgery orthodontic ttt tooth mobility,bruxism,crowding,missing or supernumerary teeth smoking
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 |
|---|---|---|
| Biologic Agent: injectable platelet rich fibrin.Also: Liquid platelet rich fibrininjection of I-PRF to thin gingival phenotype 3 times with 7 days interval between sessions. | Biological | Control group :I-PRF group |
| injecable platelet rich fibrin, and low level laser therapy radiation.injection of I-PRF+ exposure to LLLT to thin gingival phenotype 3 times with 7 days interval between sessions. | Other | Test group: injectable platelet rich fibrin+ low level laser therapy |
Primary outcome
Gingival thickness improvement in millimeters.
Time frame: 6 months after treatment
clinical parameter
Keratinized tissue width improvement in millimeters.
Time frame: 6 months after treatment
Clinincal parameter.
3 secondary outcomes
Improvement of gingival index.
Time frame: 6 months after treatment
Improvement of bleeding on probing.
Time frame: 6 months after treatment
Improvement of sulcus depth.
Time frame: 6 months after treatment
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 3 Jan 2025.
- 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 Eldawy, doctor principal investigator
MINDRAY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biologic Agent: injectable platelet rich fibrin. and injecable platelet rich fibrin, and low level laser therapy radiation. in people with Periodontal Diseases, run by Faculty of Dental Medicine for Girls 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 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 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gingival thickness improvement in millimeters. (time frame: 6 months after treatment). 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 3 Jan 2025.