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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Implant, Bone Loss, Bacterial Infections

Intervention / Treatment
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* Other: Dental Implant Placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ocean E.C.®, Avinent Implant System S.L.<br>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<br>* 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.<br>* Other names: Surgery;|
| Active Comparator: Ocean I.C.®, Avinent Implant System S.L.<br>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<br>* 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.<br>* Other names: Surgery;|
| Active Comparator: Ocean C.C.®, Avinent Implant System S.L.<br>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<br>* 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.<br>* Other names: Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Vertical bone loss in millimetres per implant and unit of time. | 12 months after prosthesis placement. | 
| Early implant failure | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implant, Internal Connection, External Connection, Conical Connection, Marginal Bone Loss, Implant Prosthetic Connection, Bacterial Leakage