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Ball Vs Locator Attachment in Overdenture Retained by Single Mandibular Implant

Primary Purpose

Edentulous Jaw

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mandibular overdenture retained with single midline implant using locator attachment
mandibular overdenture retained with single midline implant using ball attachment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Edentulous Jaw

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Completely edentulous patient
  2. Patients having enough bone for an implant length of at least 10 mm
  3. No apparent bony mal-relation.
  4. No intraoral soft and hard tissue pathology
  5. No uncontrolled systematic diseases such as hypertension, diabetes and immunodeficiency.

Exclusion Criteria:

  1. Drug or alcohol abuse,
  2. A health condition precluding surgery,
  3. Physical reasons that could affect follow-up,
  4. Psychiatric problems,
  5. Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.

Smokers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    locater attachment

    ball attachment

    Arm Description

    mandibular overdenture retained with single midline implant using locator attachment

    mandibular overdenture retained with single midline implant using ball attachment

    Outcomes

    Primary Outcome Measures

    OHRQoL (oral health related quality of life)

    Secondary Outcome Measures

    Peri-implant Plaque index
    Peri-implant Probing Depth

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    November 1, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02952274
    Brief Title
    Ball Vs Locator Attachment in Overdenture Retained by Single Mandibular Implant
    Official Title
    Comparison Between Ball and Locator Attachments in Patients Receiving Complete Mandibular Overdenture Retained by Single Midline Implant
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to compare the ball attachment to the locator attachment regarding the OHRQoL (oral health related quality of life) for completely edentulous patients retaining a mandibular overdenture with a midline placed implant
    Detailed Description
    The selected patients will be informed of the nature of the research work and informed consent will be obtained for each one of them. Only motivated patients who showed co-operation will participate in the study. Patients will be randomly divided into 2 groups. Conventional upper and lower complete dentures will be constructed before installing the implant where the lower denture will be duplicated into a radiographic stent. CBCT (cone beam computerized tomography) with lower radiographic stent in place stabilized with the upper denture using a rubber base index, will be taken to know the available bone height &width to determine the optimum implant size. Patients will receive single implant in symphyseal region of mandible. The surgical procedure is carried out under local anaesthesia, following premedication with 2 g amoxicillin (or 600mg of clindamycin) and 1 g paracetamol. After two rinses with 0.2% chlorhexidine gluconate, each lasting 1 min, the labial and lingual mucosa of the anterior mandible is locally infiltrated with 2.2 ml of mepivacaine 2% with 1 : 100,000 adrenalin. The surgical guide made from the duplicated mandibular complete denture is used to mark the implant site. A crestal incision will be performed and a full-thickness mucoperiosteal flap is raised to expose the anterior mandible. Deep dissection of this flap lingually exposes the cortical plate of the mandible and any lingual concavities. Sequential drilling & implant placement will be the next step. The implant position is adjusted to the midline of the mandible and optimum labiolingual positioning and bone levelling is performed as necessary. A healing abutment is selected to be 2mm above the mucosa. The mucosa is adjusted and sutured with interrupted sutures (3-0 silk). Postoperatively, the patient should rinse with 0.2% chlorhexidine gluconate mouthwash for 2 weeks. Immediately following implant surgery, generous relief of the existing mandibular complete denture is carried out and a tissue conditioner is applied to the undersurface of the denture. The patient leaves after the surgical operation wearing both the complete maxillary denture opposed by the tissue-conditioned mandibular complete denture. A period of 8 weeks will be allowed for healing and osseointegration. Then, patients will be recalled for implant loading. The interventional group will receive locator and the control group will receive a standard Ball attachment. Locator attachment and a ball and socket attachment were randomly assigned to each patient using a computer generated randomization table. In (Group I) The healing abutment was first removed and the gingival collar irrigated with 0.12% chlorhexidine. The locator attachment was inserted into the implant fixture and torqued to 30 N cm, leaving the attachment base protruding at least 2 mm above the tissue surface. The denture surface of the denture was further relieved to increase the spaces surrounding the attachment assembly and to accommodate the self-curing denture base resin. The denture was inserted after the relief space was filled with resin, and the patient was guided to occlude at centric occlusion. The denture was removed after the resin was cured and adjusted accordingly to assure a comfortable fit. In (Group2) Patients will receive a standard ball abutment instead of the locator abutment, however the procedures are the same. Sample Size If there is truly no difference between two groups then 22 patients are required to be 80% sure that the limit of a two sided 90% confidence interval will exclude a difference in means more than 10. The sample size was done by Sealed Envelope Ltd. 2012 Recruitment Fresh Patient attending in the outpatient clinic in faculty of oral and dental medicine Cairo University will be enrolled in the study Patient from last year records in the outpatient clinic in faculty of oral and dental medicine Cairo University will be contacted by phone and recalled. Another eligibility examination will be made the researcher and Research will be discussed with all patients and only motivated patient will join the research Sequence generation Is done by computer on the internet by random.org which gives true random numbers Implementation: Randomized: Computer generated allocation sequence, enrollment and assignment of the participants Blinding Outcome assessor will be blinded as well as the data analysts for the primary outcome. It would not be possible to blind the participant or the care provider or the assessor for the second outcome. Data collection and management: Data for the primary and secondary outcome will be collected at the day of the surgery and after 3 months on loading of implant and after 6 and 9 months. All data will be saved digitally twice on two separate computers by researcher and the house officer and revised by the supervisor at the end of the data collection. Participant files are to be stored in numerical order and stored in computer of the removable prosthodontic department Statistical methods: Data will be analyzed using IBM (International Business Machines) SPSS advanced statistics (statistical package for social sciences), version 21 (SPSS Inc, Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Data will be explored for normality using kolmogorov-Smirnov test and Shapiro Wilk test. Comparison between two groups for normally distributed numeric variables will be done using the student's t-test while for non normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed. Data Monitoring: data monitoring committee is independent from the sponsor & competing interest. None of the supervisors or the researcher has any conflict of interest with Locator producing companies and is a member of the speaker panel of any company. Harm: Any complication with implant placement will be reported & managed in the usual way. There is minimal risk of harm associated with the trial. Auditing: will be independent from the investigator, with every time the data is collected

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous Jaw

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    locater attachment
    Arm Type
    Active Comparator
    Arm Description
    mandibular overdenture retained with single midline implant using locator attachment
    Arm Title
    ball attachment
    Arm Type
    Active Comparator
    Arm Description
    mandibular overdenture retained with single midline implant using ball attachment
    Intervention Type
    Device
    Intervention Name(s)
    mandibular overdenture retained with single midline implant using locator attachment
    Intervention Type
    Device
    Intervention Name(s)
    mandibular overdenture retained with single midline implant using ball attachment
    Primary Outcome Measure Information:
    Title
    OHRQoL (oral health related quality of life)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Peri-implant Plaque index
    Time Frame
    6 months
    Title
    Peri-implant Probing Depth
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Completely edentulous patient Patients having enough bone for an implant length of at least 10 mm No apparent bony mal-relation. No intraoral soft and hard tissue pathology No uncontrolled systematic diseases such as hypertension, diabetes and immunodeficiency. Exclusion Criteria: Drug or alcohol abuse, A health condition precluding surgery, Physical reasons that could affect follow-up, Psychiatric problems, Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site. Smokers
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed El-Baz
    Phone
    01011168773
    Ext
    +2
    Email
    ahmedbaz88@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Sayed
    Phone
    01006410903
    Ext
    +2

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Ball Vs Locator Attachment in Overdenture Retained by Single Mandibular Implant

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