Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

NCT03256409 | Completed DMC

• 1 other identifier: Gastrovital&Development
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study was to compare the surface roughness (Ra) of the implant retained mandibular bar overdenture (BOD) and the implant retained mandibular ball joint overdenture (BJOD) in jaw and its relation with the adhesion of molds and yeasts and mesophyll aerobe, in time 30 to 180 days in mouth. Five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (BOD); and five systems joint ball Klockner® Implant System; Soadco Inc., Escaldes-Engordany; Andorra (BJOD), were used in two parallel groups of five participants, in an essay to simple blind person. To 30 to 180 days they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml). The Ra:um (the 30th and 180th): BOD, 0.965 - 1.351; BJOD, 1.325 - 2.384. Adhesion: molds and yeasts, BOD, 2.6 x 102 and 4.6 x 103; BJOD, 3.0 x 102 and 5.3 x 104. Adhesion: mesophyll aerobe, BOD, 3.8 x 106 and 5.8 x 106; BJOD, 4.3 x 106 and 7.1 x 107. The BOD and BJOD, present different Ra (P \< 0.05) to 30 to 180 days. To 30 days (P = 0.489) differences do not exist as regards the adhesion of molds and yeasts and mesophyll aerobe between both overdentures. To 180 days (P = 0.723) differences exist as regards the adhesion of mold and yeast and mesophyll aerobe, being major in BJOD.

Conditions

Adhesiveness

Keywords

biomaterials; methacrylates; microbiology; implant dentistry/implantology; removable prosthodontics; clinical studies/trials

Outcome Measures

Primary Outcomes (2)

• Average values of surface roughness (Ra) and correlation of independent test in implant-retained mandibular bar overdentures (BOD) 30 - 180 days.

  The average Ra Group 1: BOD titanium bar CARES® and synOcta Straumann® in 30 days: 0.965um. In 180 days: 1.351um. 95% confidence and Shapiro Wilk (P \> 0.05), determines normal distribution. Correlation of independent test (P \< 0.05) 30 days (P= 0.000) and 180 days (P=0.001) determined different Ra. Ll: Lower limit; Ul: Upper limit.

  Change from 30 to 180 days

• Average values of surface roughness (Ra) and correlation of independents tests in implant-retained ball joint overdentures (BJOD) 30 - 180 days.

  The average Ra Group 2: BJOD Klockner® in 30 days: 1.325um. 180 days: 2.384 um. 95% confidence and Shapiro Wilk (P \> 0.05), determines normal distribution. Correlation of independent test (P \< 0.05) 30 days (P=0.000) and 180 days (P=0.000) determined different Ra. Ll: Lower limit; Ul: Upper limit.

  Change from 30 to 180 days

Secondary Outcomes (2)

• Average values of mold and yeast adhesion and correlation of independents tests in implant-retained mandibular bar overdentures (BOD) and implant-retained mandibular ball joint overdentures (BJOD) 30 - 180 days

  Change from 30 to 180 days

• Average values of mesophyll aerobe adhesion and correlation of independents tests in implant-retained mandibular bar overdentures (BOD) and implant-retained mandibular ball joint overdentures (BJOD) 30 - 180 days

  Change from 30 to 180 days

Study Arms (2)

Five Bar overdenture: BOD

EXPERIMENTAL

Five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (Bar overdenture: Group 1) For the manufacture of the overdentures it was used as material of choice Lucitone 199® (Dentsply International Inc. York, PA) and for the adaptation of the retention systems it was used Softreliner Tough Soft® Tocuyama Dental Corporation Inc., Japan. The working protocol for determining the BOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator. Patients were randomly assigned to group 1. The BOD were removed at 30 - 180 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml).

Other: Adherence mold and yeast and mesophyll aerobe; Other: Surface Roughness (Ra)

Five Ball Joint Overdenture: BJOD

EXPERIMENTAL

Five systems ball joint Klockner® Implant System; Soadco Inc., Escaldes-Engordany, Andorra (Ball Joint Overdenture: Group 2) For the manufacture of the overdentures it was used as material of choice Lucitone 199® (Dentsply International Inc. York, PA) and for the adaptation of the retention systems it was used Softreliner Tough Soft® Tocuyama Dental Corporation Inc., Japan. The working protocol for determining the BJOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator. Patients were randomly assigned to group 2. The s BJOD were removed at 30 - 180 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml).

Other: Adherence mold and yeast and mesophyll aerobe; Other: Surface Roughness (Ra)

Interventions

Adherence mold and yeast and mesophyll aerobe OTHER

Adherence mold and yeast and mesophyll aerobe to BOD and BJOD Microbial populations have been controlled in the saliva at initial time and adherence at 30 - 180 days after the overdentures in the mouth. The saliva sample was obtained from the patient in a sterile sputum collection bottle through a sterile solution. The overdenture samples were extracted and processed for analysis. Each sample was submerged in ¼ sterile Ringer and subjected to vigorous ultrasound shaking. From each of the microbial suspensions, successive dilutions were made to determine the total number of viable microorganisms present. Total count of mold and yeast and total count of mesophyll aerobe were performed.

Also known as: Five BOD and Five BJOD

Five Ball Joint Overdenture: BJOD; Five Bar overdenture: BOD

Surface Roughness (Ra) OTHER

The surface roughness of BOD and BJOD was determined with the rugosimeter the Mitutoyo Surfest SJ-301® (Mitutoyo Corporation Inc., Kanagawa, Japan), through a displacement force of 4mN and of the tray to 0.5 mm/s and back to 1 mm/s (Murtra and Arcís,1999). The roughness profile Ra was evaluated and determined in microns (ųm) through five readings for each of the samples in the study respectively.

Also known as: Five BOD and Five BJOD

Five Ball Joint Overdenture: BJOD; Five Bar overdenture: BOD

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Total edentulous mandible from 50 to 60 years of age
• Absence of systemic conditions.

You may not qualify if:

• Hyperplasia and history of periodontal disease
• Patients with local and/or systemic antimicrobial treatment within 72 hours prior to evaluation during the study
• Signs of severe oral parafunction

Sponsors & Collaborators

• Gastrovital: lead

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MeSH Terms

Interventions

Yeast, Dried

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rocío Violeta Valenzuela-Narváez, PhD DDS

  CONCYTEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The working protocol for determining the BOD Ra and BJOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator and the following working methodology was considered: Information to the patient and obtainment of clinical data and patient informed consent. Patients were randomly assigned to group 1 and group 2. The saliva sample was obtained in each patient for the microbiological before the installation of the overdentures. BODs and BJODs were installed in each patient and according to each case. The BOD and BJOD were removed at 30 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml). For the study at 180 days the BODs and the BJODs were installed in each patient. BODs and BJODs were removed after this time to proceed to the evaluation of surface roughness and adhesion of mold and yeast and mesophyll aerobe under the same parameters mentioned above.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS

Model Details: The study presents the results of a sample of ten patients randomly assigned to receive implant-retained overdentures and divided into two parallel groups of five participants in a single-blind trial at a follow-up period of 30 - 180 days permanence in the mouth. Five overdentures were made for each group: Group 1: BOD: five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (BOD). Group 2: BJOD: five systems ball joint Klockner® Implant System; Soadco Inc., Escaldes-Engordany, Andorra were used in two parallel groups of five participants, in an essay to simple blind person.

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 22, 2017
• Study Start: January 5, 2016
• Primary Completion: January 11, 2017
• Study Completion: June 20, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share