Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02789306
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Maintenance Therapy on Peri-implant Diseases
Sponsor:
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Organization:
Study Overview
Official Title:
Influence of Maintenance Therapy on Peri-implant Disease
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIMT
Brief 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. 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
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
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):
1. Presence of plaque is recorded as 0 (no) or 1 (presence)
2. Degree of gingival redness recorded as 0 (no) or 1 (presence)
3. Depth bag measured from the gingival margin to the base of the bag in mm;
4. clinical attachment level (CAL) by the number of exposed threads measured
5. Bleeding on probing (BOP) recorded as 0 (no) or 1 (presence)
6. Discharge is recorded as 0 (no) or 1 (presence)
7. 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')
\- 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):
1. Presence of plaque is recorded as 0 (no) or 1 (presence)
2. Degree of gingival redness recorded as 0 (no) or 1 (presence)
3. Depth bag measured from the gingival margin to the base of the bag in mm;
4. clinical attachment level (CAL) by the number of exposed threads measured
5. Bleeding on probing (BOP) recorded as 0 (no) or 1 (presence)
6. Discharge is recorded as 0 (no) or 1 (presence)
7. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: