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Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.

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ClinicalTrials.gov Identifier: NCT03528330
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
David Peñarrocha Oltra, University of Valencia

Tracking Information
First Submitted Date  ICMJE March 3, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE January 8, 2018
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
Peri-implant bone level changes [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
calculated using intraoral digital periapical radiographs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • Implant failure [ Time Frame: 3 years ]
    Requiring removal
  • Prosthetic complications [ Time Frame: 3 years ]
    Screw loosening or fracture, fracture of the prosthesis or of the ceramic
  • Resonance frequency analysis values [ Time Frame: a. implant placement (baseline) b. abutment connection (8-12 weeks) ]
    Measured using Ostell Mentor
  • Probing pocket depth [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
    Measurement of peri-implant pocket depth with a periodontal probe
  • Microbial loads [ Time Frame: 12 months after loading ]
    Quantities of different microbial species assessed using 16s metagenomics
  • Plaque [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
    Presence or absence of plaque
  • Bleeding on probing [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
    Presence or absence of bleeding after probing pocket depth
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Implant failure [ Time Frame: 3 years ]
    Requiring removal
  • Prosthetic complications [ Time Frame: 3 years ]
    Screw loosening or fracture, fracture of the prosthesis or of the ceramic
  • Resonance frequency analysis values [ Time Frame: a. implant placement (baseline) b. abutment connection (8-12 weeks) ]
    Measured using Ostell Mentor
  • Probing pocket depth [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
    Measurement of peri-implant pocket depth with a periodontal probe
  • Microbial loads [ Time Frame: 12 months after loading ]
    Quantities of different microbial species assessed using 16s metagenomics
  • Plaque score [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
    Presence or absence of plaque
  • Bleeding on probing [ Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months). ]
    Presence or absence of bleeding after probing pocket depth
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Official Title  ICMJE Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Brief Summary

This study designed as a randomized controlled split-mouth trial will be conducted at the Dental Clinic of the University of Valencia. The aim will be to assess differences in clinical, radiological and microbiological outcomes between implants with 2 different connections: internal hexagon and conical connection. Following the premises, to minimize the bias related to prosthetic phase and maximize the effect of connections on MBL changes, a 1abutment-1time protocol will be used.

The study hypothesis is that there will be no statistically significant differences between both implant connections.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Bone Loss, Alveolar
  • Dental Implant Failed
Intervention  ICMJE
  • Device: Rehabilitation with dental implant with internal hexagon connection

    All patients will receive an implant with internal hexagon connection. All implants will be10 mm in length and 3.75 mm in diameter. Implants will be inserted slightly subcrestal. Bone levels will be measured using a calibrated probe.

    Torque insertion will be assed using W&H machine Once inserted, implants will be connected to smart pegs to test primary stability.

    A periapical x-ray will be done after the operation. Thereafter, a specific coping for digital impression will be connected to the implant and a digital impression will be taken. Aim of this procedure will be to produce a screw retained definitive zirconia prosthesis to be adapted at the time of second surgery

  • Device: Rehabilitation with dental implant with conical connection

    All patients will receive an implant with conical connection. All implants will be10 mm in length and 3.75 mm in diameter. Implants will be inserted slightly subcrestal. Bone levels will be measured using a calibrated probe.

    Torque insertion will be assed using W&H machine Once inserted, implants will be connected to smart pegs to test primary stability.

    A periapical x-ray will be done after the operation. Thereafter, a specific coping for digital impression will be connected to the implant and a digital impression will be taken. Aim of this procedure will be to produce a screw retained definitive zirconia prosthesis to be adapted at the time of second surgery

Study Arms  ICMJE
  • Active Comparator: Internal hexagon connection

    Small flaps will be elevated to reduce any kind of injury on the periosteum and maintain the blood supply during the healing period.

    Patients will receive 2 implants. One implant (assigned randomly) will have internal hexagon connection.

    The Internal Hex (IH) implant has a 2.5mm internal hexagon and a 90° cone. The platform diameter is Ø3.5mm.

    Intervention: Device: Rehabilitation with dental implant with internal hexagon connection
  • Experimental: Conical connection

    Small flaps will be elevated to reduce any kind of injury on the periosteum and maintain the blood supply during the healing period.

    Patients will receive 2 implants. One implant (assigned randomly) will have internal hexagon connection.

    The Conical Standard (CS) implant has a 2.5mm internal hexagon and 22° cone. The platform diameter is Ø3.1mm.

    Intervention: Device: Rehabilitation with dental implant with conical connection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • able to sign an informed consent form
  • aged 25 years or more
  • Any patient requiring two implant-supported crowns in the lower or upper jaw
  • Kennedy class I, II, and III;
  • teeth extracted at least 6 months before implant placement;
  • sufficient bone volumes to accommodate dental implants without augmentation procedure

Exclusion Criteria:

  • General medical and/or psychiatric contraindications to implant surgery,
  • Pregnancy or nursing,
  • Heavy smoking (more than 10 cigarettes/day),
  • Treatment with anticoagulant drugs (International Normalized Ratio under 1.8), bisphosphonates, steroid therapy or anticonvulsants drugs.
  • No regenerated bone
  • Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
  • Patients with history of alcohol, narcotics or drug abuse. (Alcoholism: more than two bottles of beer per day)
  • Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment, or who have been administered radiotherapy in the last 5 years. (Patients through at any time received radiotherapy to the head and neck region should be excluded anyway.)
  • Metabolic bone disorders
  • Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
  • Degenerative diseases.
  • Osteoradionecrosis.
  • Renal failure.
  • Organ transplant recipients.
  • HIV positive.
  • Malignant diseases.
  • Diseases that compromise the immune system.
  • Unbalanced diabetes mellitus. (HbA1c above 6.5), Uncontrolled endocrine diseases
  • Psychotic diseases.
  • Hypersensitivity to one of the components of the implant in general and titanium in particular.
  • Women who are pregnant or lactating.
  • Lack of patient cooperation.
  • Parafunctional habits, such as Bruxism or Temporomandibular joint disease.
  • Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus, malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: David Peñarrocha Oltra 649952560 david.penarrocha@uv.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528330
Other Study ID Numbers  ICMJE H1506438439563
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Peñarrocha Oltra, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Valencia
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP