Bone Loss, AlveolarNCT03528330
Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
A study testing Rehabilitation with dental implant with internal hexagon connection and Rehabilitation with dental implant with conical connection in people with Bone Loss, Alveolar and Dental Implant Failed, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar, Dental Implant Failed
- What is being tested?
- Rehabilitation with dental implant with internal hexagon connection and Rehabilitation with dental implant with conical connection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Spain1 site
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Valencia, 46010
About this study
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.
- Conditions
- Bone Loss, Alveolar, Dental Implant Failed
- Being tested
- Rehabilitation with dental implant with internal hexagon connection, Rehabilitation with dental implant with conical connection
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with dental implant with internal hexagon connectionDevice
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 connectionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Internal hexagon connection | Active comparator | 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. Receives: Device: Rehabilitation with dental implant with internal hexagon connection |
| Conical connection | Experimental | 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. Receives: Device: Rehabilitation with dental implant with conical connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant bone level changes
calculated using intraoral digital periapical radiographs
Measured: 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 (7)
Implant failure
Requiring removal
Measured: 3 years
Prosthetic complications
Screw loosening or fracture, fracture of the prosthesis or of the ceramic
Measured: 3 years
Resonance frequency analysis values
Measured using Ostell Mentor
Measured: a. implant placement (baseline) b. abutment connection (8-12 weeks)
Probing pocket depth
Measurement of peri-implant pocket depth with a periodontal probe
Measured: 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).
Microbial loads
Quantities of different microbial species assessed using 16s metagenomics
Measured: 12 months after loading
Plaque
Presence or absence of plaque
Measured: 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).
Bleeding on probing
Presence or absence of bleeding after probing pocket depth
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start8 Jan 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peñarrocha Oltra, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528330
- Sponsor's protocol ID
- H1506438439563
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2018
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
- ClinicalTrials.gov ID
- NCT03528330
- Acronym / sponsor ID
- H1506438439563
- Conditions
- Bone Loss, Alveolar, Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal hexagon connection | Active comparator | Device: Rehabilitation with dental implant with internal hexagon connectionSmall 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. |
| Conical connection | Experimental | Device: Rehabilitation with dental implant with conical connectionSmall 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation with dental implant with internal hexagon connectionAll 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 | Device | Internal hexagon connection |
| Rehabilitation with dental implant with conical connectionAll 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 | Device | Conical connection |
Primary outcome
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
7 secondary outcomes
Implant failure
Time frame: 3 years
Prosthetic complications
Time frame: 3 years
Resonance frequency analysis values
Time frame: a. implant placement (baseline) b. abutment connection (8-12 weeks)
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).
Microbial loads
Time frame: 12 months after loading
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation with dental implant with internal hexagon connection and Rehabilitation with dental implant with conical connection in people with Bone Loss, Alveolar and Dental Implant Failed, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.