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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Implant Failed; Bone Loss, Alveolar
• Intervention / Treatment: Device: Rehabilitation with dental implant with internal hexagon connection; Device: Rehabilitation with dental implant with conical connection

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Internal hexagon connection; 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.	Device: Rehabilitation with dental implant with internal hexagon connection; 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
Experimental: Conical connection; 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.	Device: Rehabilitation with dental implant with conical connection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant bone level changes	calculated using intraoral digital periapical radiographs	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 Measures

Outcome Measure	Measure Description	Time Frame
Implant failure	Requiring removal	3 years
Prosthetic complications	Screw loosening or fracture, fracture of the prosthesis or of the ceramic	3 years
Resonance frequency analysis values	Measured using Ostell Mentor	a. implant placement (baseline) b. abutment connection (8-12 weeks)
Probing pocket depth	Measurement of peri-implant pocket depth with a periodontal probe	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).
Microbial loads	Quantities of different microbial species assessed using 16s metagenomics	12 months after loading
Plaque	Presence or absence of plaque	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).
Bleeding on probing	Presence or absence of bleeding after probing pocket depth	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).

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 3, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 11, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: H1506438439563

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No