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

March 27, 2020 updated by: Octavi Camps-Font, University of Barcelona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Laura Rubianes-Porta, DDS, MS
  • Phone Number: +34630873804
  • Email: od074964@uic.es

Study Contact Backup

  • Name: Octavi J. Camps-Font, DDS, MS
  • Phone Number: +34665980569

Study Locations

  • Spain
    • Catalunya
      • L'Hospitalet De Llobregat, Catalunya, Spain, 08903
        • Recruiting
        • University of Barcelona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roxana Ghiorghiu, DDS, MS
        • Principal Investigator:
          • Laura Rubianes-Porta, DDS, MS
        • Sub-Investigator:
          • Anna Piñol-Olea, DDS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ocean E.C.®, Avinent Implant System S.L.
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.
Other: Dental Implant Placement
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.
Other Names:
  • Surgery
Active Comparator: Ocean I.C.®, Avinent Implant System S.L.
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 internal hexagon connection.
Other: Dental Implant Placement
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.
Other Names:
  • Surgery
Active Comparator: Ocean C.C.®, Avinent Implant System S.L.
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 conical connection.
Other: Dental Implant Placement
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.
Other Names:
  • Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vertical Marginal Bone Loss (VMBL)
Time Frame: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.
Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical Marginal Bone Loss Tax
Time Frame: 12 months after prosthesis placement.
Vertical bone loss in millimetres per implant and unit of time.
12 months after prosthesis placement.
Early implant failure
Time Frame: Since implant placement (Timing 0) through prosthesis placement (Timing 1).
Implant with mobility or failure of the osseointegration process before the prosthesis placement.
Since implant placement (Timing 0) through prosthesis placement (Timing 1).
Late implant failure
Time Frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Implant with mobility or failure of the osseointegration process after the prosthesis placement.
Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Probing pocket depth
Time Frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
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).
Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal recession
Time Frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
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).
Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal hyperplasia
Time Frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
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).
Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Clinical attachment level
Time Frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
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).
Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
O'Leary plaque index
Time Frame: First visit
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.
First visit
Bleeding on probing
Time Frame: Since first visit through study completion (Timing 5), an average of 1 year.
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.
Since first visit through study completion (Timing 5), an average of 1 year.
Suppuration on probing
Time Frame: Since first visit through study completion (Timing 5), an average of 1 year.
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.
Since first visit through study completion (Timing 5), an average of 1 year.
Prosthetic complications
Time Frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
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.
Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Bacterial leakage
Time Frame: 12 months after prosthesis placement.
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.
12 months after prosthesis placement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Investigators

  • Study Director: Rui Figueiredo, DDS, MS, PhD, University of Barcelona
  • Principal Investigator: Octavi Camps-Font, DDS, MS, University of Barcelona
  • Study Chair: Eduard Valmaseda-Castellón, DDS, MS, PhD, University of Barcelona
  • Principal Investigator: Roxana Ghiorghiu, DDS, MS, University of Barcelona
  • Principal Investigator: Laura Rubianes-Porta, DDS, MS, University of Barcelona
  • Principal Investigator: Anna Piñol-Olea, DDS, MS, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Anticipated)

June 13, 2021

Study Completion (Anticipated)

December 13, 2021

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBarcelonaOralSurgery2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Under request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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