Periodontal DiseaseNCT02126267
Evaluation of Techniques for Scaling and Root Planing and One Stage Full Mouth Disinfection
A study testing Scaling and root planing, Full mouth disinfection and Chlorhexidine gel and gluconate in people with Periodontal Disease and Chronic Periodontitis, run by Centro Universitario de Lavras at 1 site in Brazil.
Trial summary
Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontal Disease, Chronic Periodontitis
- What is being tested?
- Scaling and root planing, Full mouth disinfection and Chlorhexidine gel and gluconate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Mar 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of slight-moderate chronic periodontitis
Who cannot join
- Those who were making regular use of antibiotics or anti-inflammatory drugs or had done up to three months before the beginning of the study;
- those who were making regular use (twice a day) of oral rinses with chlorhexidine or essential oils or have made regular use within three months prior to study entry;
- individuals with a history of sensitivity to chlorhexidine or azithromycin;
- subjects undergoing periodontal therapy include dental scaling procedures in the 12 months preceding the start of the study;
- subjects with impaired bifurcation or trifurcation class III;
- who required antibiotic prophylaxis for conducting clinical periodontal examination
- subjects with removable partial dentures and removable or fixed orthodontic appliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Evaluation of Techniques for Scaling and Root Planing Per Quadrant and One Stage Full Mouth Disinfection Associated With Azithromycin or Chlorhexidine: Randomized Controlled Trial
Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin.
Read the detailed description
Seventy -seven systemically healthy subjects with chronic periodontitis were randomly included in 6 different predefined groups. The following periodontal parameters were evaluated: probing depth , clinical attachment level , plaque index, gingival index and percentage of areas affected by periodontal disease. Microbiologically were evaluated the bacterial load and specific load of five bacterias: The quantification of the bacteria was performed by real-time Polymerase Chain Reaction . The clinical and microbial baseline evaluations were performed ( periodontal pre- therapy) , 90 and 180 days after treatment.
- Conditions
- Periodontal Disease, Chronic Periodontitis
- Being tested
- Scaling and root planing, Full mouth disinfection, Chlorhexidine gel and gluconate, Chlorhexidine gluconate solution, Azithromycin
- Keywords
- periodontal disease, therapy, anti-bacterial agents, Randomized Controlled Trials
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
Full mouth disinfectionProcedure or surgery
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
Chlorhexidine gel and gluconateDrug
application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)
Chlorhexidine gluconate solutionDrug
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
AzithromycinDrug
Azithromycin (500 mg) once daily for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Full mouth disinfection - FMD | Experimental | n = 10: Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days Receives: Procedure: Full mouth disinfection |
| FMD + chlorhexidine (FMD-CX) | Experimental | n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase. Receives: Procedure: Full mouth disinfection; Drug: Chlorhexidine gel and gluconate; Drug: Chlorhexidine gluconate solution |
| FMD + azithromycin (FMD-AZ) | Experimental | n = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the scaling. Receives: Procedure: Full mouth disinfection; Drug: Azithromycin |
| Scaling and root planing (SRP) | Experimental | (n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions; Receives: Procedure: Scaling and root planing |
| SRP + azithromycin (SRP-AZ) | Experimental | n = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the last scaling hemi-arch; Receives: Procedure: Scaling and root planing; Drug: Azithromycin |
| SRP + chlorhexidine (SRP-CX) | Experimental | n = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling Receives: Procedure: Scaling and root planing; Drug: Chlorhexidine gluconate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical attachment
In this parameter we will evaluate the distance from the cement-enamel junction to the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters
Measured: Baseline and 180 days after treatment
Secondary outcomes (1)
Change in probing depth
In this parameter we will evaluate the distance between the gingival margin and the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters
Measured: Baseline and 180 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionMar 2014
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 Periodontal DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Lavras
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Responsible party
- Principal investigator, Douglas Campideli Fonseca, Centro Universitario de Lavras
- Investigators
- Douglas C Fonseca, Ms, Principal investigator, Universitary Center of Lavras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126267
- Sponsor's protocol ID
- 07172212.3.0000.5149
- Status last verified
- Apr 2014
- First submitted
- 21 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Emingil G, Han B, Ozdemir G, Tervahartiala T, Vural C, Atilla G, Baylas H, Sorsa T. Effect of azithromycin, as an adjunct to nonsurgical periodontal treatment, on microbiological parameters and gingival crevicular fluid biomarkers in generalized aggressive periodontitis. J Periodontal Res. 2012 Dec;47(6):729-39. doi: 10.1111/j.1600-0765.2012.01488.x. Epub 2012 May 9.
PubMed 22571226
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of Techniques for Scaling and Root Planing Per Quadrant and One Stage Full Mouth Disinfection Associated With Azithromycin or Chlorhexidine: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02126267
- Acronym / sponsor ID
- 07172212.3.0000.5149
- Conditions
- Periodontal Disease, Chronic Periodontitis
- Keywords
- periodontal disease, therapy, anti-bacterial agents, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centro Universitario de LavrasUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Apr 2014 (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.
Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin.
Detailed description
Seventy -seven systemically healthy subjects with chronic periodontitis were randomly included in 6 different predefined groups. The following periodontal parameters were evaluated: probing depth , clinical attachment level , plaque index, gingival index and percentage of areas affected by periodontal disease. Microbiologically were evaluated the bacterial load and specific load of five bacterias: The quantification of the bacteria was performed by real-time Polymerase Chain Reaction . The clinical and microbial baseline evaluations were performed ( periodontal pre- therapy) , 90 and 180 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Full mouth disinfection - FMD | Experimental | Procedure: Full mouth disinfectionn = 10: Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days |
| FMD + chlorhexidine (FMD-CX) | Experimental | Procedure: Full mouth disinfection, Drug: Chlorhexidine gel and gluconate, Drug: Chlorhexidine gluconate solutionn = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase. |
| FMD + azithromycin (FMD-AZ) | Experimental | Procedure: Full mouth disinfection, Drug: Azithromycinn = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the scaling. |
| Scaling and root planing (SRP) | Experimental | Procedure: Scaling and root planing(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions; |
| SRP + azithromycin (SRP-AZ) | Experimental | Procedure: Scaling and root planing, Drug: Azithromycinn = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the last scaling hemi-arch; |
| SRP + chlorhexidine (SRP-CX) | Experimental | Procedure: Scaling and root planing, Drug: Chlorhexidine gluconate solutionn = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of slight-moderate chronic periodontitis
Key exclusion criteria (7 listed)
- Those who were making regular use of antibiotics or anti-inflammatory drugs or had done up to three months before the beginning of the study;
- those who were making regular use (twice a day) of oral rinses with chlorhexidine or essential oils or have made regular use within three months prior to study entry;
- individuals with a history of sensitivity to chlorhexidine or azithromycin;
- subjects undergoing periodontal therapy include dental scaling procedures in the 12 months preceding the start of the study;
- subjects with impaired bifurcation or trifurcation class III;
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 |
|---|---|---|
| Scaling and root planingScaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions; | Procedure or surgery | SRP + azithromycin (SRP-AZ), SRP + chlorhexidine (SRP-CX), Scaling and root planing (SRP) |
| Full mouth disinfectionProcedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days | Procedure or surgery | FMD + azithromycin (FMD-AZ), FMD + chlorhexidine (FMD-CX), Full mouth disinfection - FMD |
| Chlorhexidine gel and gluconateapplication of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds) | Drug | FMD + chlorhexidine (FMD-CX) |
| Chlorhexidine gluconate solutionHome use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling. | Drug | FMD + chlorhexidine (FMD-CX), SRP + chlorhexidine (SRP-CX) |
| AzithromycinAzithromycin (500 mg) once daily for 3 consecutive days. | Drug | FMD + azithromycin (FMD-AZ), SRP + azithromycin (SRP-AZ) |
Primary outcome
Change in clinical attachment
Time frame: Baseline and 180 days after treatment
In this parameter we will evaluate the distance from the cement-enamel junction to the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters
1 secondary outcome
Change in probing depth
Time frame: Baseline and 180 days after treatment
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 29 Apr 2014.
- Results publication: PubMed 22571226Emingil G, Han B, Ozdemir G, Tervahartiala T, Vural C, Atilla G, Baylas H, Sorsa T. Effect of azithromycin, as an adjunct to nonsurgical periodontal treatment, on microbiological parameters and gingival crevicular fluid biomarkers in generalized aggressive periodontitis. J Periodontal Res. 2012 Dec;47(6):729-39. doi: 10.1111/j.1600-0765.2012.01488.x. Epub 2012 May 9.
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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.
Douglas C Fonseca, Ms principal investigator
Universitary Center of Lavras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing, Full mouth disinfection and Chlorhexidine gel and gluconate in people with Periodontal Disease and Chronic Periodontitis, run by Centro Universitario de Lavras at 1 site in Brazil.
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 1 inclusion and 7 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 29 Apr 2014. 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 Brazil. 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. 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?
Change in clinical attachment (time frame: Baseline and 180 days after 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 NCT02126267, 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 29 Apr 2014.