NCT05482490

Maintenance Protocol for Implant Supported Hybrid Prosthesis.

Status unknown NA Last updated 1 August 2022

What this trial tests

NA trial testing Maintenance protocol for the hygiene of implant supported prosthesis in Implant Infection in 130 participants. Status unknown.

Timeline

1 October 2022

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Cagliari
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	130
Start date	1 October 2022
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• Maintenance protocol for the hygiene of implant supported prosthesis

Conditions studied

• Implant Infection — all drugs for Implant Infection →

Sponsor

University of Cagliari

Who can join

Eligibility, any sex, with Implant Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.