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

Sponsor

University of Barcelona (Other)

Overall Status

Unknown status

CT.gov ID

NCT04328051

Collaborator

(none)

105

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implant Bone Loss Bacterial Infections	Other: Dental Implant Placement	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 13, 2018

Anticipated Primary Completion Date :

Jun 13, 2021

Anticipated Study Completion Date :

Dec 13, 2021

Arms and Interventions

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

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.

Other: Dental Implant Placement

Other Names:

Surgery

Active Comparator: Ocean C.C.®, Avinent Implant System S.L.

Other: Dental Implant Placement

Other Names:

Surgery

Outcome Measures

Primary Outcome Measures

Change in Vertical Marginal Bone Loss (VMBL) [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.

Secondary Outcome Measures

Vertical Marginal Bone Loss Tax [12 months after prosthesis placement.]
Vertical bone loss in millimetres per implant and unit of time.
Early implant failure [Since implant placement (Timing 0) through prosthesis placement (Timing 1).]
Implant with mobility or failure of the osseointegration process before the prosthesis placement.
Late implant failure [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.
Probing pocket depth [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).
Mucosal recession [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).
Mucosal hyperplasia [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).
Clinical attachment level [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).
O'Leary plaque index [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.
Bleeding on probing [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.
Suppuration on probing [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.
Prosthetic complications [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.
Bacterial leakage [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.