PeriodontitisPAPDNCT02407379
Diode Laser and SRP in Chronic Periodontitis
A study testing PAPD+SRP in people with Periodontitis, run by Odontostomatologic Laser Therapy Center, Florence, Italy at 1 site in Italy.
Trial summary
The purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- PAPD+SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to 28 Aug 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontitis:Presence of at least two teeth with at least one site with pocket probing depth (PD) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (BOP)
- A minimum of five natural teeth in each studied quadrant.
Who cannot join
- History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases)
- Pregnancy or lactation
- Chronic high-dose steroid use
- Previous or current radiation or immunosuppressive therapies
- Ongoing orthodontic treatments
- Extensive carious lesions
Show all 9Show fewer
- Recurrent antibiotic medications during the 6 months preceding the study
- Class III tooth mobility
- Heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis
The purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis.
Read the detailed description
The present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. Twenty-four patients were studied. Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP. Sham-treatment was similar but with switched off laser.
Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.
- Conditions
- Periodontitis
- Being tested
- PAPD+SRP, Sham-laser +SRP
- Keywords
- Laser, periodontitis, scaling root planing, bacteria, PMN
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAPD+SRPProcedure or surgery
Photoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications).
Sham-laser +SRPProcedure or surgery
Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| PAPD+SRP Quadrant | Active comparator | This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP Receives: Procedure: PAPD+SRP |
| Sham-laser + SRP | Sham comparator | This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP Receives: Procedure: Sham-laser +SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD
Change in probing pocket depth
Measured: baseline, 1 year
Secondary outcomes (4)
CAL
Change in mean attachment level
Measured: baseline, 1 year
BoP
Change in mean bleeding on probing
Measured: baseline, 1 year
PMN, DEC, bacteria
Change in mean additional disease markers, namely polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples.
Measured: baseline, 1 year
Patient-reported outcomes
Individual evaluation of pain/discomfort assessed by a visual analogue score interview
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completion28 Aug 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odontostomatologic Laser Therapy Center, Florence, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Giannelli, Principal investigator, Odontostomatologic laser therapy center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407379
- Sponsor's protocol ID
- OLTC014
- Acronym
- PAPD
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Giannelli M, Materassi F, Fossi T, Lorenzini L, Bani D. Treatment of severe periodontitis with a laser and light-emitting diode (LED) procedure adjunctive to scaling and root planing: a double-blind, randomized, single-center, split-mouth clinical trial investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med Sci. 2018 Jul;33(5):991-1002. doi: 10.1007/s10103-018-2441-9. Epub 2018 Jan 18.
PubMed 29349511
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis
- ClinicalTrials.gov ID
- NCT02407379
- Acronym / sponsor ID
- PAPD / OLTC014
- Conditions
- Periodontitis
- Keywords
- Laser, periodontitis, scaling root planing, bacteria, PMN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Odontostomatologic Laser Therapy Center, Florence, ItalyUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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 purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis.
Detailed description
The present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. Twenty-four patients were studied. Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP. Sham-treatment was similar but with switched off laser.
Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAPD+SRP Quadrant | Active comparator | Procedure: PAPD+SRPThis quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP |
| Sham-laser + SRP | Sham comparator | Procedure: Sham-laser +SRPThis quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Periodontitis:Presence of at least two teeth with at least one site with pocket probing depth (PD) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (BOP)
- A minimum of five natural teeth in each studied quadrant.
Key exclusion criteria (9 listed)
- History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases)
- Pregnancy or lactation
- Chronic high-dose steroid use
- Previous or current radiation or immunosuppressive therapies
- Ongoing orthodontic treatments
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 |
|---|---|---|
| PAPD+SRPPhotoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications). | Procedure or surgery | PAPD+SRP Quadrant |
| Sham-laser +SRPSham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing | Procedure or surgery | Sham-laser + SRP |
Primary outcome
PD
Time frame: baseline, 1 year
Change in probing pocket depth
4 secondary outcomes
CAL
Time frame: baseline, 1 year
BoP
Time frame: baseline, 1 year
PMN, DEC, bacteria
Time frame: baseline, 1 year
Patient-reported outcomes
Time frame: baseline, 1 year
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 31 Aug 2018.
- Results publication: PubMed 29349511Giannelli M, Materassi F, Fossi T, Lorenzini L, Bani D. Treatment of severe periodontitis with a laser and light-emitting diode (LED) procedure adjunctive to scaling and root planing: a double-blind, randomized, single-center, split-mouth clinical trial investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med Sci. 2018 Jul;33(5):991-1002. doi: 10.1007/s10103-018-2441-9. Epub 2018 Jan 18.
- 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.
Marco Giannelli principal investigator
Odontostomatologic laser therapy center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAPD+SRP in people with Periodontitis, run by Odontostomatologic Laser Therapy Center, Florence, Italy 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 2 inclusion and 9 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 31 Aug 2018. 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. 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?
PD (time frame: baseline, 1 year). 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 NCT02407379, 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 31 Aug 2018.