Aggressive Periodontitis, GeneralizedNCT03140059
Comparison Between Surgical Access and Repeated Applications of APDT
A study testing Open flap debridement and Repeated application of aPDT in people with Aggressive Periodontitis, Generalized, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis, Generalized
- What is being tested?
- Open flap debridement and Repeated application of aPDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Mar 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
- Good general health;
- Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
Who cannot join
- Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- Have used antibiotics and anti-inflammatories in the last six months;
- Smoke ≥ 10 cigarettes/day;
- Pregnant or lactating;
- Chronic use of medications that may alter the response of periodontal tissues;
- Indication of antibiotic prophylaxis for dental procedures;
About this study
Official title: Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial
The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
Read the detailed description
Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, the aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
- Conditions
- Aggressive Periodontitis, Generalized
- Being tested
- Open flap debridement, Repeated application of aPDT
- Keywords
- surgical procedure, residual pockets, agressive periodontitis, antimicrobial photodynamic therapy
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridementProcedure or surgery
Also called Surgical therapy
Open flap debridement will be performed to decontaminate root surface
Repeated application of aPDTProcedure or surgery
Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Open flap debridement | Active comparator | In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets. Receives: Procedure: Open flap debridement |
| Repeated application of aPDT | Active comparator | In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing. Receives: Procedure: Repeated application of aPDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
Measured: 6 months
Secondary outcomes (1)
Probing depth
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 posted4 May 2017
- Study startJun 2016
- Primary completionJun 2017
- Study completionMar 2018 (estimated)
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 Aggressive Periodontitis, GeneralizedStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, DDS, PhD, Study director, Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140059
- Sponsor's protocol ID
- SurgeryPDT
- Status last verified
- Oct 2017
- First submitted
- 2 May 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
PubMed 19563331
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03140059
- Acronym / sponsor ID
- SurgeryPDT
- Conditions
- Aggressive Periodontitis, Generalized
- Keywords
- surgical procedure, residual pockets, agressive periodontitis, antimicrobial photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 May 2017 (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 aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
Detailed description
Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, the aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open flap debridement | Active comparator | Procedure: Open flap debridementIn this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets. |
| Repeated application of aPDT | Active comparator | Procedure: Repeated application of aPDTIn this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
- Good general health;
- Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
Key exclusion criteria (6 listed)
- Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- Have used antibiotics and anti-inflammatories in the last six months;
- Smoke ≥ 10 cigarettes/day;
- Pregnant or lactating;
- Chronic use of medications that may alter the response of periodontal tissues;
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 |
|---|---|---|
| Open flap debridementAlso: Surgical therapyOpen flap debridement will be performed to decontaminate root surface | Procedure or surgery | Open flap debridement |
| Repeated application of aPDTRepeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively. | Procedure or surgery | Repeated application of aPDT |
Primary outcome
Clinical attachment level
Time frame: 6 months
1 secondary outcome
Probing depth
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Background: PubMed 19563331Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
- Individual participant dataSharing planned: Undecided
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.
Mauro P Santamaria, DDS, PhD study director
Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
Questions about this trial
What is this clinical trial studying?
A study testing Open flap debridement and Repeated application of aPDT in people with Aggressive Periodontitis, Generalized, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Oct 2017. 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. 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?
Results are not available in the source record.
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?
Clinical attachment level (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 NCT03140059, 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 18 Oct 2017.