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

U

University of Valencia

Status

Unknown

Conditions

Bone Loss, Alveolar
Dental Implant Failed

Treatments

Device: Rehabilitation with dental implant with internal hexagon connection
Device: Rehabilitation with dental implant with conical connection

Study type

Interventional

Funder types

Other

Identifiers

NCT03528330
H1506438439563

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Internal hexagon connection
Active Comparator group
Description:
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.
Treatment:
Device: Rehabilitation with dental implant with internal hexagon connection
Conical connection
Experimental group
Description:
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.
Treatment:
Device: Rehabilitation with dental implant with conical connection

Trial contacts and locations

1

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Central trial contact

David Peñarrocha Oltra

Data sourced from clinicaltrials.gov

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