Aggressive PeriodontitisPhase 4NCT02466646
Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
A Phase 4 study testing Klorhex® Gel, rinse and spray, Conventional IPT and Full-mouth IPT in people with Aggressive Periodontitis, run by Marmara University.
Trial summary
The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with… 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
- What is being tested?
- Klorhex® Gel, rinse and spray, Conventional IPT and Full-mouth IPT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No systemic diseases that could influence the outcome of the therapy
- No smoking
- No medications affecting periodontal tissues
- No pregnancy or lactation
- Presence of at least 15 teeth
Who cannot join
- Received antibiotic treatment in the previous 3 months
- Smokers
- Pregnancy and lactation
- Received periodontal treatment in the previous 6 months
- Presence of less than 15 teeth
- Presence of systemic diseases
About this study
Official title: Evaluation of Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels and Periodontal Pathogens After Full-Mouth Disinfection Initial Periodontal Treatment in Generalized Aggressive Periodontitis Patients
The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment.
The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.
Read the detailed description
The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.
- Conditions
- Aggressive Periodontitis
- Being tested
- Klorhex® Gel, rinse and spray, Conventional IPT, Full-mouth IPT
- Keywords
- Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klorhex® Gel, rinse and sprayDrug
Also called FMD
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).
Conventional IPTProcedure or surgery
Also called Q-SRP
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Full-mouth IPTProcedure or surgery
Also called FM-SRP
Initial periodontal treatment was performed in 2 sessions within 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Full-mouth Disinfection IPT | Active comparator | Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks). Receives: Drug: Klorhex® Gel, rinse and spray |
| Conventional IPT | Experimental | Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. Receives: Procedure: Conventional IPT |
| Full-mouth IPT | Experimental | Initial periodontal treatment was performed in 2 sessions within 24 hours. Receives: Procedure: Full-mouth IPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Measured: 6 months after initial periodontal treatment
Secondary outcomes (11)
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Level of A. Actinomycetemcomitans
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Level of Porphyromonas Gingivalis
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Level of Fusobacterium Nucleatum
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Level of Parvimonas Micra
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Bleeding on Probing
Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome.
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Plaque Index
Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Gingival Index
Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Clinical Attachment Level
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Level of Prevotella Intermedia
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Level of Campylobacter Rectus
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Basak Dogan, Prof. Dr., Study director, Marmara University, Faculty of Dentistry, Department of PeriodontologyDilek Mamaklioglu, Dr., Principal investigator, Marmara University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466646
- Sponsor's protocol ID
- SAG-C-DRP-280214-0043
- Status last verified
- May 2020
- First submitted
- 27 May 2015
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aimetti M, Romano F, Guzzi N, Carnevale G. Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. J Clin Periodontol. 2012 Mar;39(3):284-94. doi: 10.1111/j.1600-051X.2011.01795.x. Epub 2012 Jan 4.
PubMed 22220822Mongardini C, van Steenberghe D, Dekeyser C, Quirynen M. One stage full- versus partial-mouth disinfection in the treatment of chronic adult or generalized early-onset periodontitis. I. Long-term clinical observations. J Periodontol. 1999 Jun;70(6):632-45. doi: 10.1902/jop.1999.70.6.632.
PubMed 10397519de Lima Oliveira AP, de Faveri M, Gursky LC, Mestnik MJ, Feres M, Haffajee AD, Socransky SS, Teles RP. Effects of periodontal therapy on GCF cytokines in generalized aggressive periodontitis subjects. J Clin Periodontol. 2012 Mar;39(3):295-302. doi: 10.1111/j.1600-051X.2011.01817.x. Epub 2011 Nov 30.
PubMed 22126282
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels and Periodontal Pathogens After Full-Mouth Disinfection Initial Periodontal Treatment in Generalized Aggressive Periodontitis Patients
- ClinicalTrials.gov ID
- NCT02466646
- Acronym / sponsor ID
- SAG-C-DRP-280214-0043
- Conditions
- Aggressive Periodontitis
- Keywords
- Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 9 Jun 2020
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 determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment.
The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.
Detailed description
The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-mouth Disinfection IPT | Active comparator | Drug: Klorhex® Gel, rinse and sprayInitial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks). |
| Conventional IPT | Experimental | Procedure: Conventional IPTInitial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. |
| Full-mouth IPT | Experimental | Procedure: Full-mouth IPTInitial periodontal treatment was performed in 2 sessions within 24 hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No systemic diseases that could influence the outcome of the therapy
- No smoking
- No medications affecting periodontal tissues
- No pregnancy or lactation
- Presence of at least 15 teeth
Key exclusion criteria (6 listed)
- Received antibiotic treatment in the previous 3 months
- Smokers
- Pregnancy and lactation
- Received periodontal treatment in the previous 6 months
- Presence of less than 15 teeth
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 |
|---|---|---|
| Klorhex® Gel, rinse and sprayAlso: FMDInitial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks). | Drug | Full-mouth Disinfection IPT |
| Conventional IPTAlso: Q-SRPInitial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. | Procedure or surgery | Conventional IPT |
| Full-mouth IPTAlso: FM-SRPInitial periodontal treatment was performed in 2 sessions within 24 hours. | Procedure or surgery | Full-mouth IPT |
Primary outcome
Probing Depth
Time frame: 6 months after initial periodontal treatment
11 secondary outcomes
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Level of A. Actinomycetemcomitans
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Level of Porphyromonas Gingivalis
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Level of Fusobacterium Nucleatum
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Level of Parvimonas Micra
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Bleeding on Probing
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Plaque Index
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Gingival Index
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Clinical Attachment Level
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Level of Prevotella Intermedia
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Level of Campylobacter Rectus
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22220822Aimetti M, Romano F, Guzzi N, Carnevale G. Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. J Clin Periodontol. 2012 Mar;39(3):284-94. doi: 10.1111/j.1600-051X.2011.01795.x. Epub 2012 Jan 4.
- Background: PubMed 10397519Mongardini C, van Steenberghe D, Dekeyser C, Quirynen M. One stage full- versus partial-mouth disinfection in the treatment of chronic adult or generalized early-onset periodontitis. I. Long-term clinical observations. J Periodontol. 1999 Jun;70(6):632-45. doi: 10.1902/jop.1999.70.6.632.
- Background: PubMed 22126282de Lima Oliveira AP, de Faveri M, Gursky LC, Mestnik MJ, Feres M, Haffajee AD, Socransky SS, Teles RP. Effects of periodontal therapy on GCF cytokines in generalized aggressive periodontitis subjects. J Clin Periodontol. 2012 Mar;39(3):295-302. doi: 10.1111/j.1600-051X.2011.01817.x. Epub 2011 Nov 30.
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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.
Basak Dogan, Prof. Dr. study director
Marmara University, Faculty of Dentistry, Department of Periodontology
Dilek Mamaklioglu, Dr. principal investigator
Marmara University, Faculty of Dentistry, Department of Periodontology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Klorhex® Gel, rinse and spray, Conventional IPT and Full-mouth IPT in people with Aggressive Periodontitis, run by Marmara University.
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: finished, as of the sponsor's last update on 9 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 6 months after initial periodontal treatment). 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 NCT02466646, which also lists 3 linked publications.
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 9 Jun 2020.