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

NCT03528330 | Unknown

• 1 other identifier: H1506438439563
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Implant failure

  3 years

• Prosthetic complications

  3 years

• Resonance frequency analysis values

  a. implant placement (baseline) b. abutment connection (8-12 weeks)

• 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).

• Microbial loads

  12 months after loading

Study Arms (2)

Internal hexagon connection

ACTIVE COMPARATOR

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

Conical connection

EXPERIMENTAL

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

Interventions

Rehabilitation with dental implant with internal hexagon connection 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

Internal hexagon connection

Rehabilitation with dental implant with conical connection 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

Conical connection

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Rehabilitation; Dental Implants

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

David Peñarrocha Oltra

CONTACT

649952560; david.penarrocha@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: May 17, 2018
• Study Start: January 8, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

ES (1)