Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

Adhesiveness Clinical Trial

Official title:

Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256409
• Other study ID #: Gastrovital&Development
• Status: Completed
• Phase: N/A
• First received: July 18, 2017
• Last updated: August 19, 2017
• Start date: January 5, 2016
• Est. completion date: June 20, 2017

Study information

• Verified date: August 2017
• Source: Gastrovital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 To 30 to 180 days they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).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.

Description:

Adherence mold and yeast and mesophyll aerobe to BOD and BJOD, Surface roughness (Ra), and Statistical Analyses Microbial populations have been controlled in the saliva at initial time and adherence at 30 to 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.

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.

The results of BOD and BJOD were compared for the determination of Ra and the adherence of mold and yeast and mesophyll aerobe. For this, we used the statistics Shapiro-Wilk, T and the Pearson Correlation Coefficient to determinate the relationship between the study variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 20, 2017
• Est. primary completion date: January 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

• Total edentulous mandible from 50 to 60 years of age

• Absence of systemic conditions.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adhesiveness

Intervention

Other:
• Adherence mold and yeast and mesophyll aerobe
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.
• Surface Roughness (Ra)
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 (um) through five readings for each of the samples in the study respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gastrovital

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Average adhesion values of mold and yeast. Group 1 (BOD): 30 days: 2.6 x 102 CFU/ml. Group 2 (BJOD): 30 days: 3.0 x 102 CFU/ml. Group 1 (BOD): 180 days: 4.6 x 103 CFU/ml. Group 2 (BJOD): 180 days: 5.3 x 104 CFU/ml. 95% confidence and Shapiro Wilk (P > 0.05), determines normal distribution. Correlation of independent tests 30 days (P > 0.05) BOD (P=0.051) y BJOD (P=0.052) showed no different adherence. For 180 days (P < 0.05) BOD (P=0.025) y BJOD (P=0.027) presented different adhesion. Ll: Lower limit; Ul: Upper limit	Change from 30 to 180 days
Secondary	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	Average adhesion values of mesophyll aerobe. Group 1 (BOD): 30 days: 3.8 x 106 CFU/ml. Group 2 (BJOD): 30 days: 4.3 x 106 CFU/ml. Group 1 (BOD): 180 days: 5.8 x 106 CFU/ml. Group 2 (BJOD): 180 days: 7.1 x 107 CFU/ml. 95% confidence and Shapiro Wilk (P > 0.05), determines normal distribution. Correlation of independent tests 30 days (P > 0.05) BOD (P=0.052) y BJOD (P=0.053) showed no different adherence. For 180 days (P < 0.05) BOD (P=0.000) y BJOD (P=0.000) presented different adhesion. Ll: Lower limit; Ul: Upper limit.	Change from 30 to 180 days