Implant Infection Clinical Trial
Official title:
A Novel Hygienic Maintenance Protocol for Implant Supported Hybrid Prosthesis. Prospective Clinical and Microbiological Outcomes
Verified date | July 2022 |
Source | University of Cagliari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study we intend to carry out aims to analyze the clinical and microbiological effects of a new maintenance protocol for implant-supported hybrid prostheses. The maintenance protocol we propose is based on a sequence of phases that include not only the hygiene and cleaning of the prosthesis and the implants, but also the motivation and reinforcement of oral hygiene through iconographic aid (intraoral photographs of the patient). The proposed hygiene protocol is based on a meticulous preliminary plaque disclosure, followed by a full mouth decontamination of all intraoral mucosae, a decontamination of the secondary components, specific intrasulcular decontamination of the implants depending on whether there are probes greater than or less than 5mm and finally, a decontamination and hygiene of the hybrid prosthesis, all with the help of erythritol powders and the different settings of the AirFlow Prophylaxis Master EMS (Electro Medical Systems S.A., Nyon, Switzerland) device. Clinical parameters such as plaque index (PlI), probing depth (PD), bleeding on probing (BOP) and peri-implant suppuration (PS) will be recorded immediately after removal of the prosthesis and at one month of follow-up. The collection of the microbiological sample will be carried out according to the following procedures: the implant will be isolated by suction and the use of cotton rolls, in order to avoid contamination of saliva. Four sterile endodontic paper points will be inserted into the peri-implant sulcus of each implant, placing them in the mesial, distal, lingual/palatal and buccal sites and removed after 30 seconds with tweezers by placing them in a sterile plastic tube which will be sealed immediately. The same procedure will be performed for each implant. Once the operation is completed, the tubes of each patient (one for each implant and each containing 4 paper points) will be sent for microbiological analysis. The samples will be sent to the Microbiology Laboratory of the Department of Surgical Sciences of the University of Cagliari, in order to analyze the presence of bacteria ofn the peri-implant sulci. DNA from crevicular fluid samples will then be isolated by centrifugation and analyzed by PCR (polymerase chain reaction). This biomolecular technique is based on an enzymatic reaction, in which a heat-resistant DNA polymerase (Taq Polymerase) catalyzes the specific amplification of known DNA sequences. This procedure will be performed before the hygiene protocol, immediately after and at one month of follow-up. Power analysis was employed to determine the sample size by using a .05 significance level and a power of 90% based on an effect size of 0.25. Sample size of a minimum of 130 implants (approximately 25/30 patients carrying implant supported hybrid prostheses) is required to detect significant difference between the parameters measured at the different time points using repeated measures ANOVA, however the recruitment of patients will continue through the entire first period of the execution program with no limitations even after reaching the predetermined number
Status | Not yet recruiting |
Enrollment | 130 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients with implant-supported hybrid prosthesis Exclusion Criteria: - chronic bronchitis or asthma - major systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) - Intake of antibiotics or other medication taken within the previous 28 days that may affect the outcome of the study - Confirmed or suspected intolerance to erythritol or chlorhexidine. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Duilio Casula, AOU Cagliari | Monserrato | CA |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari |
Italy,
Cha JK, Paeng K, Jung UW, Choi SH, Sanz M, Sanz-Martín I. The effect of five mechanical instrumentation protocols on implant surface topography and roughness: A scanning electron microscope and confocal laser scanning microscope analysis. Clin Oral Implan — View Citation
Cobb CM, Daubert DM, Davis K, Deming J, Flemmig TF, Pattison A, Roulet JF, Stambaugh RV. Consensus Conference Findings on Supragingival and Subgingival Air Polishing. Compend Contin Educ Dent. 2017 Feb;38(2):e1-e4. — View Citation
Riben-Grundstrom C, Norderyd O, André U, Renvert S. Treatment of peri-implant mucositis using a glycine powder air-polishing or ultrasonic device: a randomized clinical trial. J Clin Periodontol. 2015 May;42(5):462-9. doi: 10.1111/jcpe.12395. Epub 2015 Ap — View Citation
Taschieri S, Weinstein R, Del Fabbro M, Corbella S. Erythritol-Enriched Air-Polishing Powder for the Surgical Treatment of Peri-Implantitis. ScientificWorldJournal. 2015;2015:802310. doi: 10.1155/2015/802310. Epub 2015 May 6. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical parameters | plaque index (PlI) | immediately after removal of the prosthesis | |
Primary | Clinical parameters | plaque index (PlI) | one month of follow-up. | |
Primary | Clinical parameters | probing depth (PD) | immediately after removal of the prosthesis | |
Primary | Clinical parameters | probing depth (PD) | at one month of follow-up. | |
Primary | Clinical parameters | bleeding on probing (BOP) | immediately after removal of the prosthesis | |
Primary | Clinical parameters | bleeding on probing (BOP) | at one month of follow-up. | |
Primary | Clinical parameters | peri-implant suppuration (PS) | immediately after removal of the prosthesis | |
Primary | Clinical parameters | peri-implant suppuration (PS) | at one month of follow-up. | |
Primary | Microbiological parameters | Four sterile endodontic paper points will be inserted into the peri-implant sulcus of each implant, placing them in the mesial, distal, lingual/palatal and buccal sites and removed after 30 seconds with tweezers by placing them in a sterile plastic tube which will be sealed immediately. The samples will be sent to the Microbiology Laboratory in order to analyze the presence of bacteria of the peri-implant sulci. | immediately after removal of the prosthesis | |
Primary | Microbiological parameters | Four sterile endodontic paper points will be inserted into the peri-implant sulcus of each implant, placing them in the mesial, distal, lingual/palatal and buccal sites and removed after 30 seconds with tweezers by placing them in a sterile plastic tube which will be sealed immediately. The samples will be sent to the Microbiology Laboratory in order to analyze the presence of bacteria of the peri-implant sulci. | at one month of follow-up. |
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