Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

Sponsor

Gastrovital (Other)

Overall Status

Completed

CT.gov ID

NCT03256409

Collaborator

(none)

Enrollment

Arms

17.5

Actual Duration (Months)

Study Details

Study Description

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 To 30 to 180 days they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).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

Condition or Disease	Intervention/Treatment	Phase
Adhesiveness	Other: Adherence mold and yeast and mesophyll aerobe Other: Surface Roughness (Ra)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

Actual Study Start Date :

Jan 5, 2016

Actual Primary Completion Date :

Jan 11, 2017

Actual Study Completion Date :

Jun 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Five Bar overdenture: BOD 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 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. Other Names: Five BOD and Five BJOD Other: 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 (ųm) through five readings for each of the samples in the study respectively. Other Names: Five BOD and Five BJOD
Experimental: Five Ball Joint Overdenture: BJOD 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 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. Other Names: Five BOD and Five BJOD Other: 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 (ųm) through five readings for each of the samples in the study respectively. Other Names: Five BOD and Five BJOD

Arm

Intervention/Treatment

Experimental: Five Bar overdenture: BOD

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

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.

Other Names:

Five BOD and Five BJOD

Other: Surface Roughness (Ra)

Other Names:

Five BOD and Five BJOD

Experimental: Five Ball Joint Overdenture: BJOD

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 Names:

Five BOD and Five BJOD

Other: Surface Roughness (Ra)

Other Names:

Five BOD and Five BJOD

Outcome Measures

Primary Outcome Measures

Average values of surface roughness (Ra) and correlation of independent test in implant-retained mandibular bar overdentures (BOD) 30 - 180 days. [Change from 30 to 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.
Average values of surface roughness (Ra) and correlation of independents tests in implant-retained ball joint overdentures (BJOD) 30 - 180 days. [Change from 30 to 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.

Secondary Outcome Measures

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 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
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gastrovital

Investigators

Principal Investigator: Rocío Violeta Valenzuela-Narváez, PhD DDS, CONCYTEC

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Valenzuela-Narváez Rocío Violeta, PhD DDS, Gastrovital

ClinicalTrials.gov Identifier:

NCT03256409

Other Study ID Numbers:

Gastrovital&Development

First Posted:

Aug 22, 2017

Last Update Posted:

Aug 22, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Valenzuela-Narváez Rocío Violeta, PhD DDS, Gastrovital

biomaterials

methacrylates

microbiology

implant dentistry/implantology

removable prosthodontics

clinical studies/trials

Study Results

No Results Posted as of Aug 22, 2017