Clinical trial NCT03528330: Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Official title: Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss, Alveolar
Dental Implant Failed
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Peri-implant bone level changes
timeFrame: 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:
measure: Implant failure
timeFrame: 3 years
measure: Prosthetic complications
timeFrame: 3 years
measure: Resonance frequency analysis values
timeFrame: a. implant placement (baseline) b. abutment connection (8-12 weeks)
measure: Probing pocket depth
timeFrame: 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).
measure: Microbial loads
timeFrame: 12 months after loading
measure: Plaque
timeFrame: 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).
measure: Bleeding on probing
timeFrame: 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).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Study officials:
References: