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

Primary Purpose

Bone Loss, Alveolar, Dental Implant Failed

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Rehabilitation with dental implant with internal hexagon connection
Rehabilitation with dental implant with conical connection
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss, Alveolar

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis AlcanyisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Internal hexagon connection

Conical connection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Peri-implant bone level changes
calculated using intraoral digital periapical radiographs

Secondary Outcome Measures

Implant failure
Requiring removal
Prosthetic complications
Screw loosening or fracture, fracture of the prosthesis or of the ceramic
Resonance frequency analysis values
Measured using Ostell Mentor
Probing pocket depth
Measurement of peri-implant pocket depth with a periodontal probe
Microbial loads
Quantities of different microbial species assessed using 16s metagenomics
Plaque
Presence or absence of plaque
Bleeding on probing
Presence or absence of bleeding after probing pocket depth

Full Information

First Posted
March 3, 2018
Last Updated
November 11, 2018
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03528330
Brief Title
Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Official Title
Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar, Dental Implant Failed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internal hexagon connection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conical connection
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Rehabilitation with dental implant with internal hexagon connection
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Rehabilitation with dental implant with conical connection
Intervention Description
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 Measure Information:
Title
Peri-implant bone level changes
Description
calculated using intraoral digital periapical radiographs
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).
Secondary Outcome Measure Information:
Title
Implant failure
Description
Requiring removal
Time Frame
3 years
Title
Prosthetic complications
Description
Screw loosening or fracture, fracture of the prosthesis or of the ceramic
Time Frame
3 years
Title
Resonance frequency analysis values
Description
Measured using Ostell Mentor
Time Frame
a. implant placement (baseline) b. abutment connection (8-12 weeks)
Title
Probing pocket depth
Description
Measurement of peri-implant pocket depth with a periodontal probe
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).
Title
Microbial loads
Description
Quantities of different microbial species assessed using 16s metagenomics
Time Frame
12 months after loading
Title
Plaque
Description
Presence or absence of 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).
Title
Bleeding on probing
Description
Presence or absence of bleeding after 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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Peñarrocha Oltra
Phone
649952560
Email
david.penarrocha@uv.es
Facility Information:
Facility Name
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Peñarrocha Oltra
Phone
649952560
Email
david.penarrocha@uv.es

12. IPD Sharing Statement

Learn more about this trial

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

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