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COMPLETED

NCT03528330

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

Sponsor: University of Valencia

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-01-08

Completion Date

2019-12-31

Last Updated

2026-07-13

Healthy Volunteers

Yes

Conditions

Bone Loss, Alveolar Dental Implant Failed

Interventions

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

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

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.

Locations (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, Spain