Periodontal Disease Clinical Trial
— PIMTOfficial title:
Influence of Maintenance Therapy on Peri-implant Disease
Verified date | April 2017 |
Source | Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
1. What are the local and systemic factors affecting the appearance of peri-implantitis
2. The ideal frequency of supportive peri-implant maintenance in patients who do not
develop peri-implant disease
3. What is the population of patients who come to supportive peri-implant maintenance
after placement of dental implants
Status | Completed |
Enrollment | 115 |
Est. completion date | March 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Eligibility criteria: - Inclusion criteria 1. Patients between 18 and 80 years old 2. Consecutive patients that received dental implants in the last 36 months 3. Patients with partial edentulism 4. No antibiotic in the last 2 months 5. Non-smoking or smoking <10 cigarettes a day - Exclusion Criteria 1. Uncontrolled systemic diseases 2. Implants because prosthetic characteristics can not be registered probing depth or attachment level appropriately 3. Smoking> 10 cigarettes a day 4. Pregnant patients 5. Implants not placed in our center |
Country | Name | City | State |
---|---|---|---|
Spain | Florencio Monje Gil | Badajoz |
Lead Sponsor | Collaborator |
---|---|
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain | Universitat Internacional de Catalunya |
Spain,
Monje A, Aranda L, Diaz KT, Alarcón 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. Epu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
12 months | |
Secondary | 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' |
12 months | |
Secondary | 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% 5. 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) |
12 months |
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