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

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528330
• Other study ID #: H1506438439563
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: University of Valencia
• Contact: David Peñarrocha Oltra
• Phone: 649952560
• Email: david.penarrocha[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar
• Dental Implant Failed

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Spain	Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

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