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Completed

NCT Number: NCT03528330

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

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Peri-implant bone level changes

    Time frame: 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 outcomes

  1. Implant failure

    Time frame: 3 years

    Requiring removal

  2. Prosthetic complications

    Time frame: 3 years

    Screw loosening or fracture, fracture of the prosthesis or of the ceramic

  3. Resonance frequency analysis values

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

    Measured using Ostell Mentor

  4. Probing pocket depth

    Time frame: 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

  5. Microbial loads

    Time frame: 12 months after loading

    Quantities of different microbial species assessed using 16s metagenomics

  6. Plaque

    Time frame: 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

  7. Bleeding on probing

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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