PeriimplantitisPIMTNCT02789306
Preventive Maintenance Therapy on Peri-implant Diseases
An observational study of Periimplantitis and Periodontal Disease, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
In the field of periodontics, periodontal support therapy has proven to be essential in preventing the incidence or recurrence of periodontal diseases. The protocol is designed according to the risk profile of a patient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis, Periodontal Disease
- What is being tested?
- Epidemiological study on the incidence of peri-implantitis
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to 1 Mar 2017
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cross-sectional analysis that will include patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.
Who may be able to join
- Patients between 18 and 80 years old
- Consecutive patients that received dental implants in the last 36 months
- Patients with partial edentulism
- No antibiotic in the last 2 months
- Non-smoking or smoking <10 cigarettes a day
Who cannot join
- Uncontrolled systemic diseases
- Implants because prosthetic characteristics can not be registered probing depth or attachment level appropriately
- Smoking> 10 cigarettes a day
- Pregnant patients
- Implants not placed in our center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Maintenance Therapy on Peri-implant Disease
In the field of periodontics, periodontal support therapy has proven to be essential in preventing the incidence or recurrence of periodontal diseases. The protocol is designed according to the risk profile of a patient. For example, in the presence of the history of periodontal therapy, subgingival microbiota containing large numbers of spirochetes and mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance of dental implants has been recommended to prudently avoid peri-implant inflammation, Indeed, the understanding of the nature of the tissue around the implant and its pattern of disease would be important to consider, even surpassing importance. Recently, a systematic review by our group has identified the importance of maintenance therapy around implants because it can help prevent about 3 times patient-level frequency peri-implantitis.
Henceforth, our primary goal was to study the influence in a cross-sectional study of the frequency of peri-implantitis patients according to their post-implant placement and corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be shown:
- What are the local and systemic factors affecting the appearance of peri-implantitis
- The ideal frequency of supportive peri-implant maintenance in patients who do not develop peri-implant disease
- What is the population of patients who come to supportive peri-implant maintenance after placement of dental implants
Read the detailed description
Cross-sectional analysis that will include consecutive patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. a cross-sectional study calling patients to whom implants have placed them in two private practices (CICOM, Badajoz and Nart Clinica Dental, Barcelona, Spain) in the last 36 month to conduct clinical and radiographic study was performed. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.
- Clinical examination
A previously examiner (AN) calibrated perform all clinical measurements. The following clinical parameters were measured at six sites per implant (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual):
- Presence of plaque is recorded as 0 (no) or 1 (presence)
- Degree of gingival redness recorded as 0 (no) or 1 (presence)
- Depth bag measured from the gingival margin to the base of the bag in mm;
- clinical attachment level (CAL) by the number of exposed threads measured
- Bleeding on probing (BOP) recorded as 0 (no) or 1 (presence)
- Discharge is recorded as 0 (no) or 1 (presence)
- keratinized gingiva (mm)
- Radiographic parameters A previously calibrated examiner perform radiographic measurement from the neck of the implant in the mesial and distal aspect of the implants using a digitized periapical. The software used for measurements will be ImageJ (approved by the American National Institute for Research - 'NIH')
- Conditions
- Periimplantitis, Periodontal Disease
- Being tested
- Epidemiological study on the incidence of peri-implantitis
- Keywords
- Preventive therapy, Dental implants
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological study on the incidence of peri-implantitisProcedure or surgery
Clinical and radiographic examination in the routine based protocol
| Study group | Role | What they receive |
|---|---|---|
| Peri-implantitis | Peri-implantitis' - Loss radiographic bone beyond the biological bone remodeling at baseline (after prosthesis delivery) from the implant neck
* Early:> 4 mm probing depth; <25% radiographic bone loss
* Moderate:> 6mm probing depth; <50% radiographic bone loss
* Severa:> 8 mm probing depth; > 50% radiographic bone loss Receives: Procedure: Epidemiological study on the incidence of peri-implantitis | |
| Healthy | No signs of inflammation and otherwise no bone loss beyond the biological bone remodeling Receives: Procedure: Epidemiological study on the incidence of peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peri-implantitis
- 'Peri-implant health' - Absence of bleeding or inflammation
- 'Peri-implant mucositis' - Presence of bleeding (inflammation) but without bone loss
- 'Peri-implantitis' - Lost of radiographic bone from the implant neck
- Early:> 4 mm probing depth; <25% radiographic bone loss
- Moderate:> 6mm probing depth; <50% radiographic bone loss
- Severe:> 8 mm probing depth; > 50% radiographic bone loss
Measured: 12 months
Secondary outcomes (2)
Compliance of patients
- Every three months - 'compliers'
- Every 6 months - 'compliers'
- Between 6-12 months - 'erratic'
- Sporadically - 'erratic'
- Never after placement of restoration - 'non compliers'
Measured: 12 months
Local and systemic factors on peri-implantitis
- Sex (M / H)
- Age (years)
- Presence of periodontal disease in remaining teeth (determined by attachment level, probing depth, radiographic bone loss and presence of bleeding and / or discharge). By severity it will be stratified into 3 groups according to the 2015 American Academy of Periodontology (AAP):
- Mild: Probing depth 3-5mm; bone loss <15%
- Moderate: Probing depth: 5-7mm; 15-30% bone loss
- Severe: Probing depth:> 7 mm; bone loss> 30%
By location it will be stratified into two groups:
- Generalized:> 30%
- Localized: <30%
- Diabetes (Yes / No - blood glucose level mg / dl) 6. History of periodontal disease (Yes / No) 7. Time from implant placement (always> 6months after restoration) 8. Location of the implant
- Posterior maxilla (MP)
- Anterior maxilla (MA)
- Mandibular posterior (mp)
- Mandibular anterior (ma)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion1 Jan 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriimplantitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Responsible party
- Principal investigator, Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789306
- Sponsor's protocol ID
- 18002909
- Acronym
- PIMT
- Status last verified
- Apr 2017
- First submitted
- 23 May 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Monje A, Aranda L, Diaz KT, Alarcon MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epub 2015 Dec 23.
PubMed 26701350Monje A, Wang HL, Nart J. Association of Preventive Maintenance Therapy Compliance and Peri-Implant Diseases: A Cross-Sectional Study. J Periodontol. 2017 Oct;88(10):1030-1041. doi: 10.1902/jop.2017.170135. Epub 2017 May 26.
PubMed 28548886
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Maintenance Therapy on Peri-implant Disease
- ClinicalTrials.gov ID
- NCT02789306
- Acronym / sponsor ID
- PIMT / 18002909
- Conditions
- Periimplantitis, Periodontal Disease
- Keywords
- Preventive therapy, Dental implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Study start
- May 2016
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 3 Jun 2016 (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.
In the field of periodontics, periodontal support therapy has proven to be essential in preventing the incidence or recurrence of periodontal diseases. The protocol is designed according to the risk profile of a patient. For example, in the presence of the history of periodontal therapy, subgingival microbiota containing large numbers of spirochetes and mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance of dental implants has been recommended to prudently avoid peri-implant inflammation, Indeed, the understanding of the nature of the tissue around the implant and its pattern of disease would be important to consider, even surpassing importance. Recently, a systematic review by our group has identified the importance of maintenance therapy around implants because it can help prevent about 3 times patient-level frequency peri-implantitis.
Henceforth, our primary goal was to study the influence in a cross-sectional study of the frequency of peri-implantitis patients according to their post-implant placement and corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be shown:
- What are the local and systemic factors affecting the appearance of peri-implantitis
- The ideal frequency of supportive peri-implant maintenance in patients who do not develop peri-implant disease
- What is the population of patients who come to supportive peri-implant maintenance after placement of dental implants
Detailed description
Cross-sectional analysis that will include consecutive patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. a cross-sectional study calling patients to whom implants have placed them in two private practices (CICOM, Badajoz and Nart Clinica Dental, Barcelona, Spain) in the last 36 month to conduct clinical and radiographic study was performed. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.
- Clinical examination
A previously examiner (AN) calibrated perform all clinical measurements. The following clinical parameters were measured at six sites per implant (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual):
- Presence of plaque is recorded as 0 (no) or 1 (presence)
- Degree of gingival redness recorded as 0 (no) or 1 (presence)
- Depth bag measured from the gingival margin to the base of the bag in mm;
- clinical attachment level (CAL) by the number of exposed threads measured
- Bleeding on probing (BOP) recorded as 0 (no) or 1 (presence)
- Discharge is recorded as 0 (no) or 1 (presence)
- keratinized gingiva (mm)
- Radiographic parameters A previously calibrated examiner perform radiographic measurement from the neck of the implant in the mesial and distal aspect of the implants using a digitized periapical. The software used for measurements will be ImageJ (approved by the American National Institute for Research - 'NIH')
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | – | Procedure: Epidemiological study on the incidence of peri-implantitisPeri-implantitis' - Loss radiographic bone beyond the biological bone remodeling at baseline (after prosthesis delivery) from the implant neck * Early:> 4 mm probing depth; <25% radiographic bone loss * Moderate:> 6mm probing depth; <50% radiographic bone loss * Severa:> 8 mm probing depth; > 50% radiographic bone loss |
| Healthy | – | Procedure: Epidemiological study on the incidence of peri-implantitisNo signs of inflammation and otherwise no bone loss beyond the biological bone remodeling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cross-sectional analysis that will include patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.
Key inclusion criteria (5 listed)
Key exclusion criteria (5 listed)
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 |
|---|---|---|
| Epidemiological study on the incidence of peri-implantitisClinical and radiographic examination in the routine based protocol | Procedure or surgery | Healthy, Peri-implantitis |
Primary outcome
Incidence of peri-implantitis
Time frame: 12 months
* 'Peri-implant health' - Absence of bleeding or inflammation * 'Peri-implant mucositis' - Presence of bleeding (inflammation) but without bone loss * 'Peri-implantitis' - Lost of radiographic bone from the implant neck * Early:> 4 mm probing depth; <25% radiographic bone loss * Moderate:> 6mm probing depth; <50% radiographic bone loss * Severe:> 8 mm probing depth; > 50% radiographic bone loss
2 secondary outcomes
Compliance of patients
Time frame: 12 months
Local and systemic factors on peri-implantitis
Time frame: 12 months
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 25 Apr 2017.
- Results publication: PubMed 26701350Monje A, Aranda L, Diaz KT, Alarcon MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epub 2015 Dec 23.
- Derived from this study: PubMed 28548886Monje A, Wang HL, Nart J. Association of Preventive Maintenance Therapy Compliance and Peri-Implant Diseases: A Cross-Sectional Study. J Periodontol. 2017 Oct;88(10):1030-1041. doi: 10.1902/jop.2017.170135. Epub 2017 May 26.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periimplantitis and Periodontal Disease, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
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: finished, as of the sponsor's last update on 25 Apr 2017. 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 Spain. 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?
Incidence of peri-implantitis (time frame: 12 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 NCT02789306, which also lists 2 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 25 Apr 2017.