PeriodontitisNCT01598155
Effect of Supragingival Control Versus Supra- and Subgingival Control in the Periodontal Health During the Maintenance
A study of Periodontitis, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Seventy patients will be previously treated for moderate-to-severe periodontitis according to their individual needs. Thirty days after completion of periodontal treatment, these patients will be randomized to one of the following groups of periodic preventive maintenance (PPM): G1 - performed only control… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Periodontitis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Jan 2016
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 35 years;
- present at least 12 teeth in the mouth;
- patients diagnosed with moderate-to-severe periodontitis according to the criteria of the AAP (1999):
- to present ≥ 2 interproximal sites with AL ≥ 6 mm AND ≥1 interproximal site with PD ≥ 5 mm; or
- to present ≥ 2 interproximal sites with AL ≥ 3mm OR ≥ 2 interproximal sites with PD ≥ 5 mm (in different teeth).
Who cannot join
- presence of systemic conditions unfavorable to periodontal treatment (diabetes, cardiovascular changes with antimicrobial prophylaxis indicated);
- positive history of periodontal treatment and maintenance in the 12 months preceding the study;
- positive history of using anti-inflammatory drugs and antibiotics in the 3 months prior to initial consultation;
- patients in use of fixed orthodontic appliance;
- pregnant patients.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: The Effect of Supragingival Biofilm Control, and the Combination of Supra and Subgingival Biofilm Control in Periodontal Health of Patients Participating in a Periodontal Preventive Maintenance Program - A Randomized Clinical Trial.
Seventy patients will be previously treated for moderate-to-severe periodontitis according to their individual needs. Thirty days after completion of periodontal treatment, these patients will be randomized to one of the following groups of periodic preventive maintenance (PPM): G1 - performed only control supragingival; G2 - performed supra and subgingival control (when necessary).
The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis is that the effect of the supragingival control (conducted over 24 months) will be similar to the effect of the supra- and subgingival control combined, above the restoration and progression of periodontitis.
Read the detailed description
This randomized clinical trial, single-blind, aims to compare the effect of the supragingival biofilm control with the effect of supra- and subgingival biofilm control, performed by the patient-professional binomial, in periodontal patients treated, above the restoration and progression of periodontitis during the preventive periodic maintenance (PPM). Seventy patients with moderate-to-severe periodontitis, aged from 35 years, will be included. Participants will be periodontally treated according to their needs. After 30 days of the end of treatment, participants will be randomized (stratified for smoking) in two groups: Group 1 (G1)- Supragingival biofilm control; Group 2 (G2)- Supra and subgingival biofilm control. MPP consultation will take place every 3 months, for 24 months, in which the G1 will only receive procedures of supragingival biofilm control, and G2 will receive, beyond the supragingival control, subgingival interventions.
- Conditions
- Periodontitis
- Being tested
- Group 1 - Supragingival biofilm control, Group 2 - Supra- and subgingival biofilm control
- Keywords
- dental biofilm, periodontitis, maintenance, randomized clinical trial, biomarkers, bacterias, gingival crevicular fluid
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - Supragingival biofilm controlProcedure or surgery
Also called G1
30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months):
- Scaling, planning and polishing coronary surface;
- Education and motivation for oral hygiene and daily supragingival biofilm control by the patient.
Group 2 - Supra- and subgingival biofilm controlProcedure or surgery
Also called G2
30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months):
- Scaling, planning and polishing of coronary surface;
- Education and motivation for oral hygiene and daily supragingival biofilm control by the patient;
- Subgingival scaling and root planning in sites with persistent bleeding on probing and probing depth unchanged.
| Study group | Role | What they receive |
|---|---|---|
| Supragingival biofilm control | Experimental | Not described Receives: Procedure: Group 1 - Supragingival biofilm control |
| Supra- and subgingival biofilm control | Experimental | Not described Receives: Procedure: Group 2 - Supra- and subgingival biofilm control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Attachment Loss (AL)
AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.
Measured: 24 months
Secondary outcomes (2)
Periodontal Probing Depth (PPD)
PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
Measured: 24 months
Microbiological markers
To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabrina Carvalho Gomes, Federal University of Rio Grande do Sul
- Investigators
- Sabrina Carvalho Gomes, DDS, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598155
- Sponsor's protocol ID
- SGomes 01
- Status last verified
- Dec 2014
- First submitted
- 10 May 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Angst PDM, Van der Velden U, Susin C, Gomes SC. Supportive periodontal care with or without subgingival instrumentation: Microbiological results of a 2-year randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1302-1310. doi: 10.1111/jcpe.14038. Epub 2024 Jul 2.
PubMed 38956881Mendez M, Angst PDM, Oppermann RV, van der Velden U, Gomes SC. Oral health-related quality of life during supportive periodontal therapy: results from a randomized clinical trial. J Clin Periodontol. 2021 Aug;48(8):1103-1110. doi: 10.1111/jcpe.13473. Epub 2021 Jun 17.
PubMed 33899268Angst PDM, Finger Stadler A, Mendez M, Oppermann RV, van der Velden U, Gomes SC. Supportive periodontal therapy in moderate-to-severe periodontitis patients: A two-year randomized clinical trial. J Clin Periodontol. 2019 Nov;46(11):1083-1093. doi: 10.1111/jcpe.13178. Epub 2019 Sep 2.
PubMed 31378975
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supragingival Biofilm Control, and the Combination of Supra and Subgingival Biofilm Control in Periodontal Health of Patients Participating in a Periodontal Preventive Maintenance Program - A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01598155
- Acronym / sponsor ID
- SGomes 01
- Conditions
- Periodontitis
- Keywords
- dental biofilm, periodontitis, maintenance, randomized clinical trial, biomarkers, bacterias, gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 15 May 2012 (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.
Seventy patients will be previously treated for moderate-to-severe periodontitis according to their individual needs. Thirty days after completion of periodontal treatment, these patients will be randomized to one of the following groups of periodic preventive maintenance (PPM): G1 - performed only control supragingival; G2 - performed supra and subgingival control (when necessary).
The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis is that the effect of the supragingival control (conducted over 24 months) will be similar to the effect of the supra- and subgingival control combined, above the restoration and progression of periodontitis.
Detailed description
This randomized clinical trial, single-blind, aims to compare the effect of the supragingival biofilm control with the effect of supra- and subgingival biofilm control, performed by the patient-professional binomial, in periodontal patients treated, above the restoration and progression of periodontitis during the preventive periodic maintenance (PPM). Seventy patients with moderate-to-severe periodontitis, aged from 35 years, will be included. Participants will be periodontally treated according to their needs. After 30 days of the end of treatment, participants will be randomized (stratified for smoking) in two groups: Group 1 (G1)- Supragingival biofilm control; Group 2 (G2)- Supra and subgingival biofilm control. MPP consultation will take place every 3 months, for 24 months, in which the G1 will only receive procedures of supragingival biofilm control, and G2 will receive, beyond the supragingival control, subgingival interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supragingival biofilm control | Experimental | Procedure: Group 1 - Supragingival biofilm control |
| Supra- and subgingival biofilm control | Experimental | Procedure: Group 2 - Supra- and subgingival biofilm control |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age from 35 years;
- present at least 12 teeth in the mouth;
- patients diagnosed with moderate-to-severe periodontitis according to the criteria of the AAP (1999):
Key exclusion criteria (5 listed)
- presence of systemic conditions unfavorable to periodontal treatment (diabetes, cardiovascular changes with antimicrobial prophylaxis indicated);
- positive history of periodontal treatment and maintenance in the 12 months preceding the study;
- positive history of using anti-inflammatory drugs and antibiotics in the 3 months prior to initial consultation;
- patients in use of fixed orthodontic appliance;
- pregnant patients.
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 |
|---|---|---|
| Group 1 - Supragingival biofilm controlAlso: G130 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months): * Scaling, planning and polishing coronary surface; * Education and motivation for oral hygiene and daily supragingival biofilm control by the patient. | Procedure or surgery | Supragingival biofilm control |
| Group 2 - Supra- and subgingival biofilm controlAlso: G230 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months): * Scaling, planning and polishing of coronary surface; * Education and motivation for oral hygiene and daily supragingival biofilm control by the patient; * Subgingival scaling and root planning in sites with persistent bleeding on probing and probing depth unchanged. | Procedure or surgery | Supra- and subgingival biofilm control |
Primary outcome
Mean Attachment Loss (AL)
Time frame: 24 months
AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.
2 secondary outcomes
Periodontal Probing Depth (PPD)
Time frame: 24 months
Microbiological markers
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Derived from this study: PubMed 38956881Angst PDM, Van der Velden U, Susin C, Gomes SC. Supportive periodontal care with or without subgingival instrumentation: Microbiological results of a 2-year randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1302-1310. doi: 10.1111/jcpe.14038. Epub 2024 Jul 2.
- Derived from this study: PubMed 33899268Mendez M, Angst PDM, Oppermann RV, van der Velden U, Gomes SC. Oral health-related quality of life during supportive periodontal therapy: results from a randomized clinical trial. J Clin Periodontol. 2021 Aug;48(8):1103-1110. doi: 10.1111/jcpe.13473. Epub 2021 Jun 17.
- Derived from this study: PubMed 31378975Angst PDM, Finger Stadler A, Mendez M, Oppermann RV, van der Velden U, Gomes SC. Supportive periodontal therapy in moderate-to-severe periodontitis patients: A two-year randomized clinical trial. J Clin Periodontol. 2019 Nov;46(11):1083-1093. doi: 10.1111/jcpe.13178. Epub 2019 Sep 2.
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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.
Sabrina Carvalho Gomes, DDS, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Periodontitis, run by Federal University of Rio Grande do Sul 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 5 inclusion and 5 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 9 Dec 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?
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?
Mean Attachment Loss (AL) (time frame: 24 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 NCT01598155, 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 Dec 2014.