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Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

Primary Purpose

Dental Implant, Bone Loss, Bacterial Infections

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dental Implant Placement

About this trial

This is an interventional treatment trial for Dental Implant focused on measuring Dental Implant, Internal Connection, External Connection, Conical Connection, Marginal Bone Loss, Implant Prosthetic Connection, Bacterial Leakage

Eligibility Criteria

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

Inclusion Criteria:

Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
≥18-years-old patients.
Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
O'Leary plaque index and or bleeding on probing ≤25%.
Dental implants with screwed-retained prosthesis.

Exclusion Criteria:

Systemic diseases that can interfere dental implant placement.
Any contraindication for surgery procedures.
Heavy smokers (> 20cig/day).
Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
Patients who have had participated with another clinical trial the last 30 days.
Pregnant women or in lactation.
Patients with bad oral hygiene or not motivated.
Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
Guided bone regeneration required in the same time of the implant placement.

Sites / Locations

University of BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Ocean E.C.®, Avinent Implant System S.L.

Ocean I.C.®, Avinent Implant System S.L.

Ocean C.C.®, Avinent Implant System S.L.

Arm Description

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and external hexagon connection.

Outcomes

Primary Outcome Measures

Change in Vertical Marginal Bone Loss (VMBL)

Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.

Secondary Outcome Measures

Vertical Marginal Bone Loss Tax

Vertical bone loss in millimetres per implant and unit of time.

Early implant failure

Implant with mobility or failure of the osseointegration process before the prosthesis placement.

Late implant failure

Implant with mobility or failure of the osseointegration process after the prosthesis placement.

Probing pocket depth

Distance in millimetres from the gingival margin to the bottom of the periodontal pocket measured with the periodontal probe. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).

Mucosal recession

Distance in millimetres from the cemento-enamel junction of the tooth or from the implant platform to the gingival margin when it is located apically. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).

Mucosal hyperplasia

Distance in millimetres from the gingival margin to the cemento-enamel junction of the tooth or to the implant platform when the gingiva is located more coronal than them. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).

Clinical attachment level

Probing pocket depth (mm) plus the recession (mm) or probing pocket depth minus the hyperplasia (mm). Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).

O'Leary plaque index

Plaque presence in the dentogingival or implantogingival union. Determined in four points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual). Expressed as the percentage (%) of tooth or implant surfaces with plaque presence divided with the total of tooth or implant surfaces in mouth and multiplied per 100.

Bleeding on probing

Presence of blood in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with blood divided with the total of tooth or implant surfaces in mouth and multiplied per 100.

Suppuration on probing

Presence of purulent material in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with pus divided with the total of tooth or implant surfaces in mouth and multiplied per 100.

Prosthetic complications

Screw (which connects the crown with the implant) fracture or prosthesis fracture, chipping of the ceramic prosthesis, loosening of the screw (which connects the crown with the implant) or any other prosthetic components.

Bacterial leakage

Quantitative PCR in real time to determine the total amount of bacteria and in particular, of 10 pathogenic species: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Peptostreptococcus micros, Fusobacterium nucleatum, Campylobacter rectus, Eikenella corrodens and Candida albicans.

Full Information

NCT ID

NCT04328051

First Posted

June 21, 2018

Last Updated

March 27, 2020

Sponsor

University of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT04328051

Brief Title

Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

Official Title

Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 13, 2018 (Actual)

Primary Completion Date

June 13, 2021 (Anticipated)

Study Completion Date

December 13, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.

Detailed Description

Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®. Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.

6. Conditions and Keywords

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

Dental Implant, Bone Loss, Bacterial Infections

Keywords

Dental Implant, Internal Connection, External Connection, Conical Connection, Marginal Bone Loss, Implant Prosthetic Connection, Bacterial Leakage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Active comparator: Ocean E.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean I.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean C.C.®, Avinent Implant System S.L., Santpedor, Spain.

Masking

ParticipantOutcomes Assessor

Masking Description

Patient will not know the type of connection of his or her implant until the study has finished. Outcome Assessor will be blinded. In the radiographic evaluation the implant-abutment connection will be hidden to assess the marginal bone loss.

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ocean E.C.®, Avinent Implant System S.L.

Arm Type

Active Comparator

Arm Description

Arm Title

Ocean I.C.®, Avinent Implant System S.L.

Arm Type

Active Comparator

Arm Description

Arm Title

Ocean C.C.®, Avinent Implant System S.L.

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Dental Implant Placement

Other Intervention Name(s)

Surgery

Intervention Description

Antibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained.

Primary Outcome Measure Information:

Title

Change in Vertical Marginal Bone Loss (VMBL)

Description

Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.

Time Frame

Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.

Secondary Outcome Measure Information:

Title

Vertical Marginal Bone Loss Tax

Description

Vertical bone loss in millimetres per implant and unit of time.

Time Frame

12 months after prosthesis placement.

Title

Early implant failure

Description

Implant with mobility or failure of the osseointegration process before the prosthesis placement.

Time Frame

Since implant placement (Timing 0) through prosthesis placement (Timing 1).

Title

Late implant failure

Description

Implant with mobility or failure of the osseointegration process after the prosthesis placement.

Time Frame

Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Title

Probing pocket depth

Description

Time Frame

Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Title

Mucosal recession

Description

Time Frame

Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Title

Mucosal hyperplasia

Description

Time Frame

Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Title

Clinical attachment level

Description

Time Frame

Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Title

O'Leary plaque index

Description

Time Frame

First visit

Title

Bleeding on probing

Description

Time Frame

Since first visit through study completion (Timing 5), an average of 1 year.

Title

Suppuration on probing

Description

Time Frame

Since first visit through study completion (Timing 5), an average of 1 year.

Title

Prosthetic complications

Description

Time Frame

Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Title

Bacterial leakage

Description

Time Frame

12 months after prosthesis placement.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who accept signing voluntarily the informed consent before doing any action related to the study. ≥18-years-old patients. Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns. Single implants successfully osseointegrated placed at least 16 weeks post-extraction. O'Leary plaque index and or bleeding on probing ≤25%. Dental implants with screwed-retained prosthesis. Exclusion Criteria: Systemic diseases that can interfere dental implant placement. Any contraindication for surgery procedures. Heavy smokers (> 20cig/day). Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study. Patients who have had participated with another clinical trial the last 30 days. Pregnant women or in lactation. Patients with bad oral hygiene or not motivated. Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space. Guided bone regeneration required in the same time of the implant placement.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Rubianes-Porta, DDS, MS

Phone

+34630873804

od074964@uic.es

First Name & Middle Initial & Last Name or Official Title & Degree

Octavi J. Camps-Font, DDS, MS

Phone

+34665980569

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rui Figueiredo, DDS, MS, PhD

Organizational Affiliation

University of Barcelona

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eduard Valmaseda-Castellón, DDS, MS, PhD

Organizational Affiliation

University of Barcelona

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Octavi Camps-Font, DDS, MS

Organizational Affiliation

University of Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Roxana Ghiorghiu, DDS, MS

Organizational Affiliation

University of Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laura Rubianes-Porta, DDS, MS

Organizational Affiliation

University of Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anna Piñol-Olea, DDS, MS

Organizational Affiliation

University of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Barcelona

City

L'Hospitalet De Llobregat

State/Province

Catalunya

ZIP/Postal Code

08903

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Octavi Camps-Font, DDS, MS

Phone

+34665980569

occafo@gmail.com

First Name & Middle Initial & Last Name & Degree

Rui Figueiredo, DDS, MS, PhD

Phone

+34667378126

ruipfigueiredo@hotmail.com

First Name & Middle Initial & Last Name & Degree

Roxana Ghiorghiu, DDS, MS

First Name & Middle Initial & Last Name & Degree

Laura Rubianes-Porta, DDS, MS

First Name & Middle Initial & Last Name & Degree

Anna Piñol-Olea, DDS, MS

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Under request

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PubMed Identifier

4924041

Citation

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Citation

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Citation

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Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

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