GingivitisNCT03713567
Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis
A study testing Experimentally induced plaque in people with Gingivitis and Mucositis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Mucositis
- What is being tested?
- Experimentally induced plaque
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Nov 2017to 6 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years,
- History of aggressive periodontitis diagnosed according to the Armitage classification (1999) and verified by the dental chart and time of radiographic bone emission, being in periodontal maintenance for a little more than 6 months (Test group).
- Presence of teeth and implants (unitary prostheses) in the mouth; in a similar and counter-lateral position in the arch. The implants are the same system, including protective and dimensions.
- Probing Depth <5mm, in the interest sites.
- Plaque Index ≤ 20% (Silness \& Löe, 1964),
- Healthy patients
- Signature of free and informed consent.
Who cannot join
- Probing Depth> 5mm, in the interest sites.
- History of bone loss by peri-implantitis in the implant test.
- Smoking;
- Pregnancy;
- Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery);
- Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair);
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903
About this study
Official title: Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis in Patients With History of Agressive Periodontal Disease
The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals.
Read the detailed description
The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals. 20 patients will be include, 10 healthy and 10 with a history of aggressive periodontitis. All patients must present the same type of implant and abutments, with prostheses in function for more than 6 months. They should also have a tooth located in the contralateral hemi-arch in a similar position, allowing a comparison with the implant. They will be submitted to the plaque-induced inflammation by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration.
- Conditions
- Gingivitis, Mucositis
- Being tested
- Experimentally induced plaque
- Keywords
- Aggressive Periodontitis, Biomarkers, Microbiota, Dental Implants
- Medical subject headings
- Gingivitis, Mucositis, Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimentally induced plaqueBehavioural
Experimentally induced plaque by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration
| Study group | Role | What they receive |
|---|---|---|
| Experimentally induced plaque | Placebo comparator | Induced inflammation by suspension of oral hygiene Receives: Behavioral: Experimentally induced plaque |
| Experimentally induced plaque GAP | Experimental | Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis Receives: Behavioral: Experimentally induced plaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Modified Gingival Index in five different periods
According to the method of Löe \& Silness (1963) without the bleeding in the component of prueba.Measure at each visit 0 - absence of inflammation;
- - Light inflammation - slight color change and little alteration in gingival texture;
- - Moderate inflammation - moderate texture change, redness, edema, hypertrophy.
- - Severe inflammation - redness, hypertrophy.
Measured: Baseline, 7 days, 14 days, 21 days, 42 days
Secondary outcomes (2)
Changes of Angulated Bleeding Index in five different periods
0 - No bleeding.
- - Bleeding after probe stimulation.
- - Spontaneous bleeding
Measured: Baseline, 7 days, 14 days, 21 days, 42 days
Changes of Plaque Index in five different periods
0 - Absence of plaque
- - A thin layer of plaque adhered to the free gingival margin and adjacent to the dental surface. The plaque can be seen in situ only after the use of an evidentiary solution or through the passage of the periodontal probe through the dental surface.
- - Moderate accumulation in the periodontal pocket, dental surface or gingival margin, seen with the naked eye.
- - Abundance of plaque in the periodontal pocket and / or on the dental surface and gingival margin.
Measured: Baseline, 7 days, 14 days, 21 days, 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start7 Nov 2017
- Primary completion20 Mar 2018
- Study completion6 Jun 2018
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 GingivitisStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Tamires P Dutra, G, Principal investigator, School of Odontology of Piracicaba - Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713567
- Sponsor's protocol ID
- U1111-1217-5513
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dutra TP, Freitas Monteiro M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Silverio Ruiz KG, Kumar PS, Sallum EA. Clinical, immunological and microbiological evaluation of experimental peri-implant mucositis and gingivitis in subjects with Grade C, stage III/IV periodontitis background. J Clin Periodontol. 2024 Feb;51(2):209-221. doi: 10.1111/jcpe.13896. Epub 2023 Nov 8.
PubMed 37941050
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis in Patients With History of Agressive Periodontal Disease
- ClinicalTrials.gov ID
- NCT03713567
- Acronym / sponsor ID
- U1111-1217-5513
- Conditions
- Gingivitis, Mucositis
- Keywords
- Aggressive Periodontitis, Biomarkers, Microbiota, Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 19 Oct 2018 (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 objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals.
Detailed description
The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals. 20 patients will be include, 10 healthy and 10 with a history of aggressive periodontitis. All patients must present the same type of implant and abutments, with prostheses in function for more than 6 months. They should also have a tooth located in the contralateral hemi-arch in a similar position, allowing a comparison with the implant. They will be submitted to the plaque-induced inflammation by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimentally induced plaque | Placebo comparator | Behavioral: Experimentally induced plaqueInduced inflammation by suspension of oral hygiene |
| Experimentally induced plaque GAP | Experimental | Behavioral: Experimentally induced plaqueInduced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18 years,
- History of aggressive periodontitis diagnosed according to the Armitage classification (1999) and verified by the dental chart and time of radiographic bone emission, being in periodontal maintenance for a little more than 6 months (Test group).
- Presence of teeth and implants (unitary prostheses) in the mouth; in a similar and counter-lateral position in the arch. The implants are the same system, including protective and dimensions.
- Probing Depth <5mm, in the interest sites.
- Plaque Index ≤ 20% (Silness \& Löe, 1964),
Key exclusion criteria (6 listed)
- Probing Depth> 5mm, in the interest sites.
- History of bone loss by peri-implantitis in the implant test.
- Smoking;
- Pregnancy;
- Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery);
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 |
|---|---|---|
| Experimentally induced plaqueExperimentally induced plaque by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration | Behavioural | Experimentally induced plaque, Experimentally induced plaque GAP |
Primary outcome
Changes of Modified Gingival Index in five different periods
Time frame: Baseline, 7 days, 14 days, 21 days, 42 days
According to the method of Löe \& Silness (1963) without the bleeding in the component of prueba.Measure at each visit 0 - absence of inflammation; 1. - Light inflammation - slight color change and little alteration in gingival texture; 2. - Moderate inflammation - moderate texture change, redness, edema, hypertrophy. 3. - Severe inflammation - redness, hypertrophy.
2 secondary outcomes
Changes of Angulated Bleeding Index in five different periods
Time frame: Baseline, 7 days, 14 days, 21 days, 42 days
Changes of Plaque Index in five different periods
Time frame: Baseline, 7 days, 14 days, 21 days, 42 days
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 19 Oct 2018.
- Derived from this study: PubMed 37941050Dutra TP, Freitas Monteiro M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Silverio Ruiz KG, Kumar PS, Sallum EA. Clinical, immunological and microbiological evaluation of experimental peri-implant mucositis and gingivitis in subjects with Grade C, stage III/IV periodontitis background. J Clin Periodontol. 2024 Feb;51(2):209-221. doi: 10.1111/jcpe.13896. Epub 2023 Nov 8.
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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.
Tamires P Dutra, G principal investigator
School of Odontology of Piracicaba - Unicamp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimentally induced plaque in people with Gingivitis and Mucositis, run by University of Campinas, Brazil 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 7 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 19 Oct 2018. 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. 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?
Changes of Modified Gingival Index in five different periods (time frame: Baseline, 7 days, 14 days, 21 days, 42 days). 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 NCT03713567, 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 19 Oct 2018.