Peri-ImplantitisNCT03814434
Surgical Treatment of Periimplantitis in Patients With Risk Factors
A study testing Non-Surgical treatment and Surgical Treatment in people with Peri-Implantitis and Type 2 Diabetes Mellitus, run by Luiz Antonio Pugliesi Alves de Lima at 1 site in Brazil.
Trial summary
This study evaluates clinical and radiographic parameters among riks factor groups in patients with periimplantitis. This study will also treat and evaluate the patients response before and after surgical treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Type 2 Diabetes Mellitus, Smoking, Cigarette
- What is being tested?
- Non-Surgical treatment and Surgical Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 28 May 2018to 28 Jan 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Implants diagnosed with peri-implantitis with boné defects; Probing depth ≥ 4mm; Positive Bleeding on Probing and Suppuration score; Radiographic Bone Loss ≥ 3mm; Generalized Chronic Periodontitis (Armitage, 1999); Heavy Smokers (> 10 cigarets per day); Type 2 Diabetes Mellitus tipo 2 (ADA, 2005) with HbA1c between 6.5% and 7.5%
Who cannot join
- Complete Edentulism; Mucosal disease; Alcohol abuse; Systemic disease except type 2 Diabetes Mellitus, that might interfere in periimplantitis progression; Medication intake: anticoagulants, antineoplasics, contraceptives, bisphosphonates and antidepressives; Medication intake in the last 6 months: antibiotics; Medication intake in the last 3 months: antiinflammatories; Aggressive Periodontitis and Anaphylactic shock history; Periodontal treatment in the last 6 months before the baseline; Periodontal Pockets > 7mm; Light Smokers (< 10 cigarets/day); Implant Mobility.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Odontologia Universidade de Sao Paulo
São Paulo, São Paulo
Luiz Lima, PhD, +551130917418, lapalima@usp.br
Daniela Y Takahashi, MSc, +551130917833, danyumietk@usp.br
About this study
Official title: Surgical Treatment of Periimplantitis in Patients With Risk Factors: Heavy Smokers, Type 2 Diabetic and Chronic Periodontitis Patients
This study evaluates clinical and radiographic parameters among riks factor groups in patients with periimplantitis. This study will also treat and evaluate the patients response before and after surgical treatment.
Read the detailed description
Periimplantitis (PI) is an inflammatory process that results in tissue attachment bone loss around the implant. Periodontal disease, smoke habit and type 2diabetes mellitus have been recognized as potential risk factor indicators that might lead to complications establishment and progression around dental implants. PI treatment predictability has been shown limited and influenced by factors not totally clarified. The aim of this study is to evaluate the reparative response after PI surgical treatment at clinical and radiographic levelsin risk factors patients: type 2 diabetes mellitus, smokers and chronic periodontal disease.
- Being tested
- Non-Surgical treatment, Surgical Treatment
- Keywords
- peri-implantitis, inflammation, Therapy
- Medical subject headings
- Peri-Implantitis, Diabetes Mellitus, Type 2, Cigarette Smoking, Periodontal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical treatmentProcedure or surgery
Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
Surgical TreatmentProcedure or surgery
Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture
| Study group | Role | What they receive |
|---|---|---|
| Smokers with Periimplantitis group | Experimental | Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. Receives: Procedure: Non-Surgical treatment; Procedure: Surgical Treatment |
| Type 2 Diabetes with Periimplantitis group | Experimental | Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. Receives: Procedure: Non-Surgical treatment; Procedure: Surgical Treatment |
| Chronic Periodontitis with Periimplantitis group | Experimental | Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. Receives: Procedure: Non-Surgical treatment; Procedure: Surgical Treatment |
| Control with Periimplantitis group | Experimental | Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. Receives: Procedure: Non-Surgical treatment; Procedure: Surgical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bone height Gain
Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment
Measured: 3 months
Secondary outcomes (1)
Periimplant Pocket probing depth
Periimplant probing depth comparison to baseline 3 months after surgical treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start28 May 2018
- Primary completion28 Jan 2020 (estimated)
- Study completion28 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is not a randomized study. All patients will entered the study after being diagnosed with periimplantitis. Patients will be allocated to different groups according to their condition: Heavy Smokers, Type 2 Diabetes Mellitus, Chronic periodontitis and systemically healthy patients (control group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luiz Antonio Pugliesi Alves de Lima
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luiz Antonio Pugliesi Alves de Lima, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814434
- Sponsor's protocol ID
- RiskFactorsSurgPeriimplantitis
- Status last verified
- Mar 2019
- First submitted
- 21 Jan 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Periimplantitis in Patients With Risk Factors: Heavy Smokers, Type 2 Diabetic and Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03814434
- Acronym / sponsor ID
- RiskFactorsSurgPeriimplantitis
- Keywords
- peri-implantitis, inflammation, Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Luiz Antonio Pugliesi Alves de LimaUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 28 Jan 2020 (estimated)
- Study completion
- 28 Jan 2020 (estimated)
- First posted
- 24 Jan 2019 (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.
This study evaluates clinical and radiographic parameters among riks factor groups in patients with periimplantitis. This study will also treat and evaluate the patients response before and after surgical treatment.
Detailed description
Periimplantitis (PI) is an inflammatory process that results in tissue attachment bone loss around the implant. Periodontal disease, smoke habit and type 2diabetes mellitus have been recognized as potential risk factor indicators that might lead to complications establishment and progression around dental implants. PI treatment predictability has been shown limited and influenced by factors not totally clarified. The aim of this study is to evaluate the reparative response after PI surgical treatment at clinical and radiographic levelsin risk factors patients: type 2 diabetes mellitus, smokers and chronic periodontal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is not a randomized study. All patients will entered the study after being diagnosed with periimplantitis. Patients will be allocated to different groups according to their condition: Heavy Smokers, Type 2 Diabetes Mellitus, Chronic periodontitis and systemically healthy patients (control group).
| Arm | Type | Receives |
|---|---|---|
| Smokers with Periimplantitis group | Experimental | Procedure: Non-Surgical treatment, Procedure: Surgical TreatmentHeavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. |
| Type 2 Diabetes with Periimplantitis group | Experimental | Procedure: Non-Surgical treatment, Procedure: Surgical TreatmentPatients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. |
| Chronic Periodontitis with Periimplantitis group | Experimental | Procedure: Non-Surgical treatment, Procedure: Surgical TreatmentPatients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. |
| Control with Periimplantitis group | Experimental | Procedure: Non-Surgical treatment, Procedure: Surgical TreatmentSystemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Implants diagnosed with peri-implantitis with boné defects; Probing depth ≥ 4mm; Positive Bleeding on Probing and Suppuration score; Radiographic Bone Loss ≥ 3mm; Generalized Chronic Periodontitis (Armitage, 1999); Heavy Smokers (> 10 cigarets per day); Type 2 Diabetes Mellitus tipo 2 (ADA, 2005) with HbA1c between 6.5% and 7.5%
Key exclusion criteria (1 listed)
- Complete Edentulism; Mucosal disease; Alcohol abuse; Systemic disease except type 2 Diabetes Mellitus, that might interfere in periimplantitis progression; Medication intake: anticoagulants, antineoplasics, contraceptives, bisphosphonates and antidepressives; Medication intake in the last 6 months: antibiotics; Medication intake in the last 3 months: antiinflammatories; Aggressive Periodontitis and Anaphylactic shock history; Periodontal treatment in the last 6 months before the baseline; Periodontal Pockets > 7mm; Light Smokers (< 10 cigarets/day); Implant Mobility.
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 |
|---|---|---|
| Non-Surgical treatmentImplant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation | Procedure or surgery | Chronic Periodontitis with Periimplantitis group, Control with Periimplantitis group, Smokers with Periimplantitis group, Type 2 Diabetes with Periimplantitis group |
| Surgical TreatmentAnaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture | Procedure or surgery | Chronic Periodontitis with Periimplantitis group, Control with Periimplantitis group, Smokers with Periimplantitis group, Type 2 Diabetes with Periimplantitis group |
Primary outcome
Radiographic Bone height Gain
Time frame: 3 months
Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment
1 secondary outcome
Periimplant Pocket probing depth
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Peri-Implantitis
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical treatment and Surgical Treatment in people with Peri-Implantitis and Type 2 Diabetes Mellitus, run by Luiz Antonio Pugliesi Alves de Lima 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 1 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 11 Mar 2019. 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?
Contact Luiz A Lima, phd (+5511992228876, lapalima@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Bone height Gain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2019.