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

NCT ID: NCT03528330

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Bone Loss, Alveolar; Dental Implant Failed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Rehabilitation with dental implant with internal hexagon connection

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Rehabilitation with dental implant with conical connection

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

David Peñarrocha Oltra

Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

David Peñarrocha Oltra

Role: CONTACT

david.penarrocha@uv.es

649952560

Facility Contacts

David Peñarrocha Oltra

Role: primary

david.penarrocha@uv.es

649952560

Other Identifiers

H1506438439563

Identifier Type: -

Identifier Source: org_study_id