Periodontal DiseaseLaserOpenNCT07807215
Laser Assisted Open Flap Debridement
A study testing Mechanical Open Flap debridement and Laser assisted open flap debridement in people with Periodontal Disease and Periodontal Bone Loss, run by University of Bari Aldo Moro at 1 site in Italy.
Trial summary
The study involves the surgical treatment of patients with Stage I to III of periodontitis. Following completion of Steps 1 and 2 of periodontal therapy according to the EFP guidelines for the treatment of periodontitis, sites presenting with residual probing depths greater than 5 mm and non-contained periodontal… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Periodontal Bone Loss
- What is being tested?
- Mechanical Open Flap debridement and Laser assisted open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2026to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults in good general health
- Signed informed consent
- Periodontal disease treated with non surgical step.
Who cannot join
- Systemic conditions affecting bone healing
- Uncontrolled periodontal disease
- Smoking >10 cigarettes/day
- Pregnancy or lactation
- Use of medications interfering with bone metabolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mattia Marra, Dr. contact
Italy1 site
University of Bari Aldo Moro
Bari, BA, 70042
Giuseppe D'Albis, Dr., 3495103642, giuseppe.dalbis@uniba.it
Mattia Marra, Dr., mattiamarra21@gmail.com
About this study
Official title: A Comparative Evaluation of Laser Assisted Open Flap Debridement: A Clinical Trial
The study involves the surgical treatment of patients with Stage I to III of periodontitis. Following completion of Steps 1 and 2 of periodontal therapy according to the EFP guidelines for the treatment of periodontitis, sites presenting with residual probing depths greater than 5 mm and non-contained periodontal defects will undergo open-flap debridement and decontamination.
In one group, debridement and decontamination will be performed using manual and ultrasonic instrumentation, whereas in the other group, the same treatment will be supplemented with laser therapy.
- Conditions
- Periodontal Disease, Periodontal Bone Loss
- Being tested
- Mechanical Open Flap debridement, Laser assisted open flap debridement
- Keywords
- Periodontitis, Laser, Open Flap, Minimally invasive, Coagulation, decontamination
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss, Periodontitis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Open Flap debridementProcedure or surgery
Also called Periodontal flap surgery, Access flap surgery
Open-flap debridement will be performed under local anesthesia. Following incisions, a full-thickness mucoperiosteal flap will be elevated to provide adequate access to the periodontal defect and root surfaces. Granulation tissue will be carefully removed, and thorough root surface debridement will be performed using manual and ultrasonic devices. After instrumentation surgical site, the flap will be repositioned and stabilized with sutures to achieve appropriate wound closure.
Laser assisted open flap debridementProcedure or surgery
Also called Laser assisted Periodontal surgery
Open-flap debridement will be performed under local anesthesia. Following intrasulcular incisions, a full-thickness mucoperiosteal flap will be elevated to provide adequate access to the periodontal defect and root surfaces. Granulation tissue will be carefully removed, and thorough root surface debridement will be performed using manual and ultrasonic instrumentation. In the test group, laser irradiation will subsequently be performed within the periodontal pocket and on the exposed root surface as an adjunctive decontamination procedure. After instrumentation, laser treatment, and irrigation of the surgical site, the flap will be repositioned and stabilized with sutures to achieve appropriate wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Open Flap debridement | Active comparator | Patients with periodontal defects ( more than 5 mm probing after step I and II). Intervention: Following flap elevation, the defects will be instrumented using manual and ultrasonic instruments. Receives: Procedure: Mechanical Open Flap debridement |
| Laser assisted open Flap debridement | Experimental | The defects will be instrumented using manual and ultrasonic instruments follow by laser debridement and decontamination of the pockets. Receives: Procedure: Laser assisted open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal probing depth
Will be measured with dental prob the probing depth before 3 month of the surgery
Measured: 3 month
Secondary outcomes (1)
Bleeding on probing
The % os BoP will be value after 3 months.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Giuseppe D'Albis, Dr, Principal investigator, University of Bari Aldo MoroMattia Marra, Dr, Principal investigator, University of Bari Aldo MoroSaverio Capodiferro, Prof, Study director, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807215
- Sponsor's protocol ID
- OpenFlapLaser1
- Acronym
- LaserOpen
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Laser Assisted Open Flap Debridement: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07807215
- Acronym / sponsor ID
- LaserOpen / OpenFlapLaser1
- Conditions
- Periodontal Disease, Periodontal Bone Loss
- Keywords
- Periodontitis, Laser, Open Flap, Minimally invasive, Coagulation, decontamination
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 8 Sep 2026 (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.
The study involves the surgical treatment of patients with Stage I to III of periodontitis. Following completion of Steps 1 and 2 of periodontal therapy according to the EFP guidelines for the treatment of periodontitis, sites presenting with residual probing depths greater than 5 mm and non-contained periodontal defects will undergo open-flap debridement and decontamination.
In one group, debridement and decontamination will be performed using manual and ultrasonic instrumentation, whereas in the other group, the same treatment will be supplemented with laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Open Flap debridement | Active comparator | Procedure: Mechanical Open Flap debridementPatients with periodontal defects ( more than 5 mm probing after step I and II). Intervention: Following flap elevation, the defects will be instrumented using manual and ultrasonic instruments. |
| Laser assisted open Flap debridement | Experimental | Procedure: Laser assisted open flap debridementThe defects will be instrumented using manual and ultrasonic instruments follow by laser debridement and decontamination of the pockets. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults in good general health
- Signed informed consent
- Periodontal disease treated with non surgical step.
Key exclusion criteria (5 listed)
- Systemic conditions affecting bone healing
- Uncontrolled periodontal disease
- Smoking >10 cigarettes/day
- Pregnancy or lactation
- Use of medications interfering with bone metabolism
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 |
|---|---|---|
| Mechanical Open Flap debridementAlso: Periodontal flap surgery, Access flap surgeryOpen-flap debridement will be performed under local anesthesia. Following incisions, a full-thickness mucoperiosteal flap will be elevated to provide adequate access to the periodontal defect and root surfaces. Granulation tissue will be carefully removed, and thorough root surface debridement will be performed using manual and ultrasonic devices. After instrumentation surgical site, the flap will be repositioned and stabilized with sutures to achieve appropriate wound closure. | Procedure or surgery | Mechanical Open Flap debridement |
| Laser assisted open flap debridementAlso: Laser assisted Periodontal surgeryOpen-flap debridement will be performed under local anesthesia. Following intrasulcular incisions, a full-thickness mucoperiosteal flap will be elevated to provide adequate access to the periodontal defect and root surfaces. Granulation tissue will be carefully removed, and thorough root surface debridement will be performed using manual and ultrasonic instrumentation. In the test group, laser irradiation will subsequently be performed within the periodontal pocket and on the exposed root surface as an adjunctive decontamination procedure. After instrumentation, laser treatment, and irrigation of the surgical site, the flap will be repositioned and stabilized with sutures to achieve appropriate wound closure. | Procedure or surgery | Laser assisted open Flap debridement |
Primary outcome
Periodontal probing depth
Time frame: 3 month
Will be measured with dental prob the probing depth before 3 month of the surgery
1 secondary outcome
Bleeding on probing
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
Mattia Marra, Dr. contact
Giuseppe D'Albis, Dr principal investigator
University of Bari Aldo Moro
Mattia Marra, Dr principal investigator
University of Bari Aldo Moro
Saverio Capodiferro, Prof study director
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Open Flap debridement and Laser assisted open flap debridement in people with Periodontal Disease and Periodontal Bone Loss, run by University of Bari Aldo Moro at 1 site in Italy.
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 5 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe D'Albis, Dr. (3495103642, giuseppe.dalbis@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal probing depth (time frame: 3 month). 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 Sep 2026.