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AdhesivenessNCT03256409

Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

A study testing Adherence mold and yeast and mesophyll aerobe and Surface Roughness (Ra) in people with Adhesiveness, run by Gastrovital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Adhesiveness
What is being tested?
Adherence mold and yeast and mesophyll aerobe and Surface Roughness (Ra)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
5 Jan 2016to 20 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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 To 30 to 180 days they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).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

Read the 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.

Conditions
Adhesiveness
Being tested
Adherence mold and yeast and mesophyll aerobe, Surface Roughness (Ra)
Keywords
biomaterials, methacrylates, microbiology, implant dentistry/implantology, removable prosthodontics, clinical studies/trials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence mold and yeast and mesophyll aerobeOther

    Also called Five BOD and Five BJOD

    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)Other

    Also called Five BOD and Five BJOD

    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.

Study groups in NCT03256409
Study groupRoleWhat they receive
Five Bar overdenture: BODExperimentalFive 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).
Receives: Other: Adherence mold and yeast and mesophyll aerobe; Other: Surface Roughness (Ra)
Five Ball Joint Overdenture: BJODExperimentalFive 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).
Receives: Other: Adherence mold and yeast and mesophyll aerobe; Other: Surface Roughness (Ra)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from 30 to 180 days

  2. 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.

    Measured: Change from 30 to 180 days

Secondary outcomes (2)

  1. 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

    Measured: Change from 30 to 180 days

  2. 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.

    Measured: Change from 30 to 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start5 Jan 2016
  3. Primary completion11 Jan 2017
  4. Study completion20 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256409
Sponsor's protocol ID
Gastrovital&Development
Status last verified
Aug 2017
First submitted
18 Jul 2017
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stellingsma K, Slagter AP, Stegenga B, Raghoebar GM, Meijer HJ. Masticatory function in patients with an extremely resorbed mandible restored with mandibular implant-retained overdentures: comparison of three types of treatment protocols. J Oral Rehabil. 2005 Jun;32(6):403-10. doi: 10.1111/j.1365-2842.2005.01242.x.

    PubMed 15899018

  • Portmann M, Glauser R. Report of a case receiving full-arch rehabilitation in both jaws using immediate implant loading protocols: a 1-year resonance frequency analysis follow-up. Clin Implant Dent Relat Res. 2006;8(1):25-31. doi: 10.2310/j.6480.2005.00027.x.

    PubMed 16681490

  • Visser A, Meijer HJ, Raghoebar GM, Vissink A. Implant-retained mandibular overdentures versus conventional dentures: 10 years of care and aftercare. Int J Prosthodont. 2006 May-Jun;19(3):271-8.

    PubMed 16752625

  • Degidi M, Piattelli A. Immediately loaded bar-connected implants with an anodized surface inserted in the anterior mandible in a patient treated with diphosphonates for osteoporosis: a case report with a 12-month follow-up. Clin Implant Dent Relat Res. 2003;5(4):269-72. doi: 10.1111/j.1708-8208.2003.tb00210.x.

    PubMed 15127998

  • Elsyad MA, Ashmawy TM, Faramawy AG. The influence of resilient liner and clip attachments for bar-implant-retained mandibular overdentures on opposing maxillary ridge. A 5-year randomised clinical trial. J Oral Rehabil. 2014 Jan;41(1):69-77. doi: 10.1111/joor.12120. Epub 2013 Dec 20.

    PubMed 24354686

  • van Kampen F, Cune M, van der Bilt A, Bosman F. Retention and postinsertion maintenance of bar-clip, ball and magnet attachments in mandibular implant overdenture treatment: an in vivo comparison after 3 months of function. Clin Oral Implants Res. 2003 Dec;14(6):720-6. doi: 10.1046/j.0905-7161.2003.00961.x.

    PubMed 15015948

  • Lang R, Rosentritt M, Behr M, Handel G. Fracture resistance of PMMA and resin matrix composite-based interim FPD materials. Int J Prosthodont. 2003 Jul-Aug;16(4):381-4.

    PubMed 12956492

  • Panyayong W, Oshida Y, Andres CJ, Barco TM, Brown DT, Hovijitra S. Reinforcement of acrylic resins for provisional fixed restorations. Part III: effects of addition of titania and zirconia mixtures on some mechanical and physical properties. Biomed Mater Eng. 2002;12(4):353-66.

    PubMed 12652030

  • Uzun G, Keyf F. The effect of fiber reinforcement type and water storage on strength properties of a provisional fixed partial denture resin. J Biomater Appl. 2003 Apr;17(4):277-86. doi: 10.1177/0885328203017004003.

    PubMed 12797420

  • Yap AU, Mah MK, Lye CP, Loh PL. Influence of dietary simulating solvents on the hardness of provisional restorative materials. Dent Mater. 2004 May;20(4):370-6. doi: 10.1016/j.dental.2003.06.001.

    PubMed 15019452

  • Guler AU, Yilmaz F, Kulunk T, Guler E, Kurt S. Effects of different drinks on stainability of resin composite provisional restorative materials. J Prosthet Dent. 2005 Aug;94(2):118-24. doi: 10.1016/j.prosdent.2005.05.004.

    PubMed 16046965

  • Bollen CM, Lambrechts P, Quirynen M. Comparison of surface roughness of oral hard materials to the threshold surface roughness for bacterial plaque retention: a review of the literature. Dent Mater. 1997 Jul;13(4):258-69. doi: 10.1016/s0109-5641(97)80038-3.

    PubMed 11696906

  • Berger JC, Driscoll CF, Romberg E, Luo Q, Thompson G. Surface roughness of denture base acrylic resins after processing and after polishing. J Prosthodont. 2006 May-Jun;15(3):180-6. doi: 10.1111/j.1532-849X.2006.00098.x.

    PubMed 16681500

  • Keyf F, Etikan I. Evaluation of gloss changes of two denture acrylic resin materials in four different beverages. Dent Mater. 2004 Mar;20(3):244-51. doi: 10.1016/S0109-5641(03)00099-X.

    PubMed 15209229

  • Richmond R, Macfarlane TV, McCord JF. An evaluation of the surface changes in PMMA biomaterial formulations as a result of toothbrush/dentifrice abrasion. Dent Mater. 2004 Feb;20(2):124-32. doi: 10.1016/s0109-5641(03)00083-6.

    PubMed 14706795

Questions about this trial

What is this clinical trial studying?

A study testing Adherence mold and yeast and mesophyll aerobe and Surface Roughness (Ra) in people with Adhesiveness, run by Gastrovital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average values of surface roughness (Ra) and correlation of independent test in implant-retained mandibular bar overdentures (BOD) 30 - 180 days. (time frame: Change from 30 to 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256409, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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