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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Bone Loss, Alveolar Dental Implant Failed Device: Rehabilitation with dental implant with internal hexagon connection Device: Rehabilitation with dental implant with conical connection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.

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


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.

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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Implant failure [ Time Frame: 3 years ]
    Requiring removal

  2. Prosthetic complications [ Time Frame: 3 years ]
    Screw loosening or fracture, fracture of the prosthesis or of the ceramic

  3. Resonance frequency analysis values [ Time Frame: a. implant placement (baseline) b. abutment connection (8-12 weeks) ]
    Measured using Ostell Mentor

  4. 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

  5. Microbial loads [ Time Frame: 12 months after loading ]
    Quantities of different microbial species assessed using 16s metagenomics

  6. 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

  7. 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



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528330


Contacts
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Contact: David Peñarrocha Oltra 649952560 david.penarrocha@uv.es

Locations
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Spain
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis Recruiting
Valencia, Spain, 46010
Contact: David Peñarrocha Oltra    649952560    david.penarrocha@uv.es   
Sponsors and Collaborators
University of Valencia
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Responsible Party: David Peñarrocha Oltra, Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor), University of Valencia
ClinicalTrials.gov Identifier: NCT03528330    
Other Study ID Numbers: H1506438439563
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases