Aggressive Periodontitis, GeneralizedNCT03142776
Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy
A study testing periodontal debridement, photodynamic therapy and systemic clarithromycin in people with Aggressive Periodontitis, Generalized, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). 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?
- periodontal debridement, photodynamic therapy and systemic clarithromycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Aug 2015
- 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 GagP
- presence of ≥20 teeth
- <35 years of age
- periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent.
Who cannot join
- pregnant or lactating
- suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
- received antimicrobials in the previous 6 months
- taking long-term anti-inflammatory drugs
- received a course of periodontal treatment within the last 12 months
- smoked
About this study
Official title: Evaluation of the Local Effect of Nonsurgical Periodontal Treatment of Generalized Aggressive Periodontitis Associated or Not With Systemic Antibiotics and Photodynamic Therapy.: a Randomized Clinical Trial
To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).
Read the detailed description
The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
- Conditions
- Aggressive Periodontitis, Generalized
- Being tested
- periodontal debridement, photodynamic therapy, systemic clarithromycin
- Keywords
- clarithromycin, photodynamic therapy, Antimicrobial therapy, Periodontal pocket
- Medical subject headings
- Aggressive Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal debridementProcedure or surgery
Also called Ultrassonic periodontal debridement
photodynamic therapyProcedure or surgery
Also called antimicrobial photodynamic therapy
systemic clarithromycinDrug
Also called antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Periodontal debridement | Placebo comparator | Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Receives: Procedure: periodontal debridement |
| Periodontal debridement + CLM | Active comparator | Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days. Receives: Procedure: periodontal debridement; Drug: systemic clarithromycin |
| Periodontal debridement + PDT | Active comparator | Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy). Receives: Procedure: periodontal debridement; Procedure: photodynamic therapy |
| Periodontal debridement + CLM + PDT | Active comparator | Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT. Receives: Procedure: periodontal debridement; Procedure: photodynamic therapy; Drug: systemic clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
distance from bottom of pocket to the cement-enamel junction
Measured: 6 months
Secondary outcomes (1)
Probing depth
distance from the bottom of sulcus/pocket to gingival margin
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 posted5 May 2017
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
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, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142776
- Sponsor's protocol ID
- CLMPDT
- Status last verified
- Mar 2017
- First submitted
- 2 May 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arweiler NB, Pietruska M, Pietruski J, Skurska A, Dolinska E, Heumann C, Auschill TM, Sculean A. Six-month results following treatment of aggressive periodontitis with antimicrobial photodynamic therapy or amoxicillin and metronidazole. Clin Oral Investig. 2014 Dec;18(9):2129-35. doi: 10.1007/s00784-014-1193-6. Epub 2014 Feb 4.
PubMed 24493231
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Local Effect of Nonsurgical Periodontal Treatment of Generalized Aggressive Periodontitis Associated or Not With Systemic Antibiotics and Photodynamic Therapy.: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03142776
- Acronym / sponsor ID
- CLMPDT
- Conditions
- Aggressive Periodontitis, Generalized
- Keywords
- clarithromycin, photodynamic therapy, Antimicrobial therapy, Periodontal pocket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 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.
To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).
Detailed description
The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Periodontal debridement | Placebo comparator | Procedure: periodontal debridementPeriodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). |
| Periodontal debridement + CLM | Active comparator | Procedure: periodontal debridement, Drug: systemic clarithromycinPeriodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days. |
| Periodontal debridement + PDT | Active comparator | Procedure: periodontal debridement, Procedure: photodynamic therapyPeriodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy). |
| Periodontal debridement + CLM + PDT | Active comparator | Procedure: periodontal debridement, Procedure: photodynamic therapy, Drug: systemic clarithromycinPeriodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of GagP
- presence of ≥20 teeth
- <35 years of age
- periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent.
Key exclusion criteria (6 listed)
- pregnant or lactating
- suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
- received antimicrobials in the previous 6 months
- taking long-term anti-inflammatory drugs
- received a course of periodontal treatment within the last 12 months
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 |
|---|---|---|
| periodontal debridementAlso: Ultrassonic periodontal debridement | Procedure or surgery | Periodontal debridement, Periodontal debridement + CLM, Periodontal debridement + CLM + PDT, Periodontal debridement + PDT |
| photodynamic therapyAlso: antimicrobial photodynamic therapy | Procedure or surgery | Periodontal debridement + CLM + PDT, Periodontal debridement + PDT |
| systemic clarithromycinAlso: antibiotic | Drug | Periodontal debridement + CLM, Periodontal debridement + CLM + PDT |
Primary outcome
Clinical attachment level
Time frame: 6 months
distance from bottom of pocket to the cement-enamel junction
1 secondary outcome
Probing depth
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 5 May 2017.
- Background: PubMed 24493231Arweiler NB, Pietruska M, Pietruski J, Skurska A, Dolinska E, Heumann C, Auschill TM, Sculean A. Six-month results following treatment of aggressive periodontitis with antimicrobial photodynamic therapy or amoxicillin and metronidazole. Clin Oral Investig. 2014 Dec;18(9):2129-35. doi: 10.1007/s00784-014-1193-6. Epub 2014 Feb 4.
- 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
UPECLIN HC FM Botucatu Unesp
Questions about this trial
What is this clinical trial studying?
A study testing periodontal debridement, photodynamic therapy and systemic clarithromycin 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 4 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: finished, as of the sponsor's last update on 5 May 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. 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?
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 NCT03142776, 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 5 May 2017.