PeriodontitisNCT04671394
Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis
A study testing FMUD + DLIG and FMUD + ST in people with Periodontitis, run by University of Campania Luigi Vanvitelli.
Trial summary
This is a parallel-group, randomized controlled clinical trial aimed to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and green indocyanine in the full-mouth ultrasonic debridement of patients affected by periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- FMUD + DLIG and FMUD + ST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2015to 3 Sep 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe periodontitis
- Systemic health
Who cannot join
- Systemic diseases requiring antibiotic prophylaxis or other systemic medication that could affect the patient's clinical response
- Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months
- Pregnancy
About this study
Official title: The Use of Diode Laser and Green Indocyanine Solution in Adjunct to Full-mouth Ultrasonic Debridement in the Treatment of Periodontitis: a Randomized Controlled Trial
This is a parallel-group, randomized controlled clinical trial aimed to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and green indocyanine in the full-mouth ultrasonic debridement of patients affected by periodontitis.
Read the detailed description
Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and is primarily caused by the subgingival inflammation induced by the bacterial oral biofilm. Several risk factors may condition its development and progression and, if untreated, periodontitis may lead to tooth loss and severe functional and aesthetic impairments.
A central role in the non-surgical treatment of periodontitis is played by the manual and ultrasonic debridement of supra and subgingival bacterial deposits. The benefit of a fully ultrasonic approach lies in the knowledge that removing radicular structure is not a prerequisite for periodontal healing.
However, non-surgical therapy has limitations due to limited access to some sites (furcation areas, concavities, grooves, distal sites of molars, and deep pockets), which may impair periodontal healing due to the persistence of pathogens and subsequent recolonization. In this context, the use of diode laser in combination with photoactivated solutions has been proposed as an adjunct treatment to conventional periodontal therapy to enhance the antibacterial effect and improve clinical effects, especially in areas of difficult access.
In view of theme relevance and the existence of conflicting results in the literature, the aim of the present parallel-group, randomized controlled clinical trial is to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and indocyanine green (DLIG) in the full-mouth ultrasonic debridement (FMUD) of patients affected by periodontitis.
24 patients will be treated by FMUD and, after 7 days, randomly allocated half to the test and a half to the control group. In the test group, patients will receive an adjunctive treatment in periodontal sites with an initial pocket depth > 4mm consisting of the use of a diode laser device (Fox ARC, Sweden \& Martina, Due Carrare, Italy) after pocket irrigation by a solution of indocyanine green (Emundo®, Sweden\&Martina, Due Carrare, Padova, Italy), whereas the patients in the control group will receive sham treatment (ST). The same treatment will be repeated three weeks after in both the test and control groups.
Clinical assessment and microbiological analysis of subgingival plaque will be performed at baseline and after 3 and 6 months.
- Conditions
- Periodontitis
- Being tested
- FMUD + DLIG, FMUD + ST
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMUD + DLIGProcedure or surgery
Also called Diode laser: Fox ARC, Sweden & Martina, Due Carrare, Italy, indocyanine green photosensitizer solution: Emundo®, Sweden&Martina, Due Carrare, Padova, Italy
Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution
FMUD + STProcedure or surgery
Full-Mouth Ultrasonic Debridement + Sham Treatment
| Study group | Role | What they receive |
|---|---|---|
| Test (FMUD + DLIG) | Experimental | Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation. Receives: Procedure: FMUD + DLIG |
| Control (FMUD + ST) | Sham comparator | Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy. Receives: Procedure: FMUD + ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth (PD) reduction
The distance between the bottom of the pocket and the gingival margin recorded with a manual probe using a light force and measured to the closest millimeter
Measured: 6 months
Secondary outcomes (3)
Recession (REC) increase
The distance between the gingival margin and the cemento-enamel junction or the margin of the restoration.
Measured: 6 months
Clinical Attachment Level (CAL) gain
Calculated as PD plus REC.
Measured: Baseline, 3 and 6 months
Microbiological analysis
Semi-quantitative analysis by PCR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start12 Oct 2015
- Primary completion3 Sep 2018
- Study completion3 Sep 2018
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 PeriodontitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Guida, University of Campania Luigi Vanvitelli
- Investigators
- Luigi Guida, Prof., Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671394
- Sponsor's protocol ID
- Laser/01
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annunziata M, Donnarumma G, Guida A, Nastri L, Persico G, Fusco A, Sanz-Sanchez I, Guida L. Clinical and microbiological efficacy of indocyanine green-based antimicrobial photodynamic therapy as an adjunct to non-surgical treatment of periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 May;27(5):2385-2394. doi: 10.1007/s00784-023-04875-w. Epub 2023 Jan 31.
PubMed 36719506
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Diode Laser and Green Indocyanine Solution in Adjunct to Full-mouth Ultrasonic Debridement in the Treatment of Periodontitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04671394
- Acronym / sponsor ID
- Laser/01
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 17 Dec 2020 (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.
This is a parallel-group, randomized controlled clinical trial aimed to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and green indocyanine in the full-mouth ultrasonic debridement of patients affected by periodontitis.
Detailed description
Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and is primarily caused by the subgingival inflammation induced by the bacterial oral biofilm. Several risk factors may condition its development and progression and, if untreated, periodontitis may lead to tooth loss and severe functional and aesthetic impairments.
A central role in the non-surgical treatment of periodontitis is played by the manual and ultrasonic debridement of supra and subgingival bacterial deposits. The benefit of a fully ultrasonic approach lies in the knowledge that removing radicular structure is not a prerequisite for periodontal healing.
However, non-surgical therapy has limitations due to limited access to some sites (furcation areas, concavities, grooves, distal sites of molars, and deep pockets), which may impair periodontal healing due to the persistence of pathogens and subsequent recolonization. In this context, the use of diode laser in combination with photoactivated solutions has been proposed as an adjunct treatment to conventional periodontal therapy to enhance the antibacterial effect and improve clinical effects, especially in areas of difficult access.
In view of theme relevance and the existence of conflicting results in the literature, the aim of the present parallel-group, randomized controlled clinical trial is to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and indocyanine green (DLIG) in the full-mouth ultrasonic debridement (FMUD) of patients affected by periodontitis.
24 patients will be treated by FMUD and, after 7 days, randomly allocated half to the test and a half to the control group. In the test group, patients will receive an adjunctive treatment in periodontal sites with an initial pocket depth > 4mm consisting of the use of a diode laser device (Fox ARC, Sweden \& Martina, Due Carrare, Italy) after pocket irrigation by a solution of indocyanine green (Emundo®, Sweden\&Martina, Due Carrare, Padova, Italy), whereas the patients in the control group will receive sham treatment (ST). The same treatment will be repeated three weeks after in both the test and control groups.
Clinical assessment and microbiological analysis of subgingival plaque will be performed at baseline and after 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (FMUD + DLIG) | Experimental | Procedure: FMUD + DLIGPeriodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation. |
| Control (FMUD + ST) | Sham comparator | Procedure: FMUD + STPeriodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of moderate to severe periodontitis
- Systemic health
Key exclusion criteria (3 listed)
- Systemic diseases requiring antibiotic prophylaxis or other systemic medication that could affect the patient's clinical response
- Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months
- Pregnancy
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 |
|---|---|---|
| FMUD + DLIGAlso: Diode laser: Fox ARC, Sweden & Martina, Due Carrare, Italy, indocyanine green photosensitizer solution: Emundo®, Sweden&Martina, Due Carrare, Padova, ItalyFull-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution | Procedure or surgery | Test (FMUD + DLIG) |
| FMUD + STFull-Mouth Ultrasonic Debridement + Sham Treatment | Procedure or surgery | Control (FMUD + ST) |
Primary outcome
Probing depth (PD) reduction
Time frame: 6 months
The distance between the bottom of the pocket and the gingival margin recorded with a manual probe using a light force and measured to the closest millimeter
3 secondary outcomes
Recession (REC) increase
Time frame: 6 months
Clinical Attachment Level (CAL) gain
Time frame: Baseline, 3 and 6 months
Microbiological analysis
Time frame: 6 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 17 Dec 2020.
- Derived from this study: PubMed 36719506Annunziata M, Donnarumma G, Guida A, Nastri L, Persico G, Fusco A, Sanz-Sanchez I, Guida L. Clinical and microbiological efficacy of indocyanine green-based antimicrobial photodynamic therapy as an adjunct to non-surgical treatment of periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 May;27(5):2385-2394. doi: 10.1007/s00784-023-04875-w. Epub 2023 Jan 31.
- 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.
Luigi Guida, Prof. principal investigator
University of Campania Luigi Vanvitelli
Questions about this trial
What is this clinical trial studying?
A study testing FMUD + DLIG and FMUD + ST in people with Periodontitis, run by University of Campania Luigi Vanvitelli.
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 2 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Probing depth (PD) reduction (time frame: 6 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 NCT04671394, 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 17 Dec 2020.