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

Not Applicable

• Conditions: Dental Implant Failed; Bone Loss, Alveolar
• Interventions: Device: Rehabilitation with dental implant with conical connection; Device: Rehabilitation with dental implant with internal hexagon connection

• Registration Number: NCT03528330
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-11
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conical connection	Rehabilitation with dental implant with 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.
Internal hexagon connection	Rehabilitation with dental implant with 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.

Primary Outcome Measures

Name	Time	Method
Peri-implant bone level changes	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).	calculated using intraoral digital periapical radiographs

Secondary Outcome Measures

Name	Time	Method
Prosthetic complications	3 years	Screw loosening or fracture, fracture of the prosthesis or of the ceramic
Plaque	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).	Presence or absence of plaque
Resonance frequency analysis values	a. implant placement (baseline) b. abutment connection (8-12 weeks)	Measured using Ostell Mentor
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).	Measurement of peri-implant pocket depth with a periodontal probe
Implant failure	3 years	Requiring removal
Microbial loads	12 months after loading	Quantities of different microbial species assessed using 16s metagenomics
Bleeding on probing	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).	Presence or absence of bleeding after probing pocket depth

Trial Locations

Locations (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis; 🇪🇸 Valencia, Spain