Maintenance Protocol for Implant Supported Hybrid Prosthesis.

NCT05482490 | Unknown DMC

• 1 other identifier: Perio4
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Implant Infection

Keywords

Dental Implants; Hybrid prosthesis; Supportive therapy

Outcome Measures

Primary Outcomes (10)

• Clinical parameters

  plaque index (PlI)

  immediately after removal of the prosthesis

• Clinical parameters

  plaque index (PlI)

  one month of follow-up.

• Clinical parameters

  probing depth (PD)

  immediately after removal of the prosthesis

• Clinical parameters

  probing depth (PD)

  at one month of follow-up.

• Clinical parameters

  bleeding on probing (BOP)

  immediately after removal of the prosthesis

• Clinical parameters

  bleeding on probing (BOP)

  at one month of follow-up.

• Clinical parameters

  peri-implant suppuration (PS)

  immediately after removal of the prosthesis

• Clinical parameters

  peri-implant suppuration (PS)

  at one month of follow-up.

• 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

• 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.

Study Arms (1)

IFCDPprotocol

EXPERIMENTAL

Patients subjected to the novel implant-supported fixed complete dental prostheses maintenance protocol

Procedure: Maintenance protocol for the hygiene of implant supported prosthesis

Interventions

Maintenance protocol for the hygiene of implant supported prosthesis PROCEDURE

Sequence of phases that include the hygiene and cleaning of the prosthesis and the implants, the motivation of the patients and reinforcement of oral hygiene.

IFCDPprotocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with implant-supported hybrid prosthesis

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Policlinico Duilio Casula, AOU Cagliari

Monserrato, CA, 09042, Italy

Location

Related Publications (4)

• 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.

  PMID: 28156118 BACKGROUND

• 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.

  PMID: 26065025 BACKGROUND

• Riben-Grundstrom C, Norderyd O, Andre 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 Apr 30.

  PMID: 25851433 RESULT

• Cha JK, Paeng K, Jung UW, Choi SH, Sanz M, Sanz-Martin 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 Implants Res. 2019 Jun;30(6):578-587. doi: 10.1111/clr.13446. Epub 2019 May 7.

  PMID: 31022305 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 1, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be submitted for publication right after the analysis of the outcomes

Locations

IT (1)