Oral Health Quality of Life (OHQoL) Was AssessedNCT07087717
Comparison of Implants With Different Implant Surfaces.
A study testing Split-Mouth Placement of an implant with a moderately rough surface (DCC). and Split-Mouth Placement of an implant with a hybrid surface (MSC). in people with Oral Health Quality of Life (OHQoL) Was Assessed and the Effect of Surface Roughness on Crestal Bone Remodelling, run by University Ghent at 1 site in Belgium.
Trial summary
This study looks at how the surface texture of dental implants affects the surrounding bone and the overall gum health over time. It compares two types of implant surfaces: one partially smooth and one slightly rough. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oral Health Quality of Life (OHQoL) Was Assessed, the Effect of Surface Roughness on Crestal Bone Remodelling, The Effect of Surface Roughness on Peri-implant Health
- What is being tested?
- Split-Mouth Placement of an implant with a moderately rough surface (DCC). and Split-Mouth Placement of an implant with a hybrid surface (MSC).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jan 2015to 12 Dec 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Totally edentulous for at least four months
- Sufficient residual bone volume to place two implants of 4 mm in diameter and 9-11 mm in length
Who cannot join
- <21 years old
- Smoking
- General contra-indications for oral surgery, e.g., full-dose head and neck radiation, intravenously administrated bisphosphonates and current chemotherapy.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Oral Health Sciences - Department of Periodontology and Oral Implantology - P8
Ghent, 900
About this study
Official title: A Prospective Randomized Clinical Split-mouth Study on the Influence of Implant Surface Roughness on Peri-implant Bone Stability of Implants Supporting a Mandibular Overdenture.
This study looks at how the surface texture of dental implants affects the surrounding bone and the overall gum health over time. It compares two types of implant surfaces: one partially smooth and one slightly rough. The researchers also check how these implant treatments impact patients' quality of life related to oral health after 1 year and again after 8 years.
Read the detailed description
This split-mouth randomized controlled trial aimed to assess the effect of surface roughness on long-term crestal bone remodelling and peri-implant health, comparing hybrid and moderately rough implants. As a secondary aim, Oral Health Quality of Life (OHQoL) was assessed after 1 and 8 function years.
- Conditions
- Oral Health Quality of Life (OHQoL) Was Assessed, the Effect of Surface Roughness on Crestal Bone Remodelling, The Effect of Surface Roughness on Peri-implant Health
- Being tested
- Split-Mouth Placement of an implant with a moderately rough surface (DCC)., Split-Mouth Placement of an implant with a hybrid surface (MSC).
- Keywords
- implant surface, implant-supported overdenture, oral health quality of life, implant survival, hybrid implants, moderately rough implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-Mouth Placement of an implant with a moderately rough surface (DCC).Device
Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.
Split-Mouth Placement of an implant with a hybrid surface (MSC).Device
Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.
| Study group | Role | What they receive |
|---|---|---|
| DCC-implant | Active comparator | Implant with a moderatley rough surface (DCC) was placed in one part of the mandible. Receives: Device: Split-Mouth Placement of an implant with a moderately rough surface (DCC). |
| MSC-implant | Experimental | Implant with a a hybrid surface (MSC) was placed in a second part of the mandible. Receives: Device: Split-Mouth Placement of an implant with a hybrid surface (MSC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of surface roughness on long-term crestal bone remodelling.
The effect of surface roughness on long-term crestal bone remodelling is evaluated by recording crestal bone loss (mm) on intra-oral periapical radiographs of the implants.
Measured: From enrollment until 8 years.
Secondary outcomes (4)
Oral Health Quality of Life (OHQoL)
The patients were asked to complete an Oral Health Impact Profile-14 (OHIP-14) questionnaire. Score varies beween min.0 and max.56. Lower values indicate better conditions.
Measured: Assessed after 1 and 8 function years.
Peri-implant Health: Probing pocket depth
Probing pocket depth (mm) at 4 sites around the implant
Measured: At one year, 6 years, 8 years and 10 years of follow-up
Peri-implant health: Bleeding on probing
Bleeding on probing (yes/no) at 4 sites around the implant
Measured: At one year, 6 years, 8 years and 10 years of follow-up.
Peri-implant Health: Plaque
Plaque (yes/no) at 4 sites around the implant
Measured: at one year, 6 years, 8 years and 10 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start12 Jan 2015
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Health Quality of Life (OHQoL) Was AssessedStudies 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
- Parallel groups
- Model description
- In this split-mouth randomized controlled trial patients received a mandibular overdenture supported by 2 different implants. One implant had a moderately rough surface (DCC) and one implant had a hybrid surface (MSC).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten Glibert, DDS, MSc, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087717
- Sponsor's protocol ID
- EC/2014/1231/AM01 BC-8296
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glibert M, Matthys C, Maat RJ, De Bruyn H, Vervaeke S. A randomized controlled clinical trial assessing initial crestal bone remodeling of implants with a different surface roughness. Clin Implant Dent Relat Res. 2018 Oct;20(5):824-828. doi: 10.1111/cid.12652. Epub 2018 Jul 26.
PubMed 30048048
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Split-mouth Study on the Influence of Implant Surface Roughness on Peri-implant Bone Stability of Implants Supporting a Mandibular Overdenture.
- ClinicalTrials.gov ID
- NCT07087717
- Acronym / sponsor ID
- EC/2014/1231/AM01 BC-8296
- Conditions
- Oral Health Quality of Life (OHQoL) Was Assessed, the Effect of Surface Roughness on Crestal Bone Remodelling, The Effect of Surface Roughness on Peri-implant Health
- Keywords
- implant surface, implant-supported overdenture, oral health quality of life, implant survival, hybrid implants, moderately rough implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 28 Jul 2025 (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 looks at how the surface texture of dental implants affects the surrounding bone and the overall gum health over time. It compares two types of implant surfaces: one partially smooth and one slightly rough. The researchers also check how these implant treatments impact patients' quality of life related to oral health after 1 year and again after 8 years.
Detailed description
This split-mouth randomized controlled trial aimed to assess the effect of surface roughness on long-term crestal bone remodelling and peri-implant health, comparing hybrid and moderately rough implants. As a secondary aim, Oral Health Quality of Life (OHQoL) was assessed after 1 and 8 function years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this split-mouth randomized controlled trial patients received a mandibular overdenture supported by 2 different implants. One implant had a moderately rough surface (DCC) and one implant had a hybrid surface (MSC).
| Arm | Type | Receives |
|---|---|---|
| DCC-implant | Active comparator | Device: Split-Mouth Placement of an implant with a moderately rough surface (DCC).Implant with a moderatley rough surface (DCC) was placed in one part of the mandible. |
| MSC-implant | Experimental | Device: Split-Mouth Placement of an implant with a hybrid surface (MSC).Implant with a a hybrid surface (MSC) was placed in a second part of the mandible. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Totally edentulous for at least four months
- Sufficient residual bone volume to place two implants of 4 mm in diameter and 9-11 mm in length
Key exclusion criteria (3 listed)
- <21 years old
- Smoking
- General contra-indications for oral surgery, e.g., full-dose head and neck radiation, intravenously administrated bisphosphonates and current chemotherapy.
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 |
|---|---|---|
| Split-Mouth Placement of an implant with a moderately rough surface (DCC).Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient. | Device | DCC-implant |
| Split-Mouth Placement of an implant with a hybrid surface (MSC).Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient. | Device | MSC-implant |
Primary outcome
The effect of surface roughness on long-term crestal bone remodelling.
Time frame: From enrollment until 8 years.
The effect of surface roughness on long-term crestal bone remodelling is evaluated by recording crestal bone loss (mm) on intra-oral periapical radiographs of the implants.
4 secondary outcomes
Oral Health Quality of Life (OHQoL)
Time frame: Assessed after 1 and 8 function years.
Peri-implant Health: Probing pocket depth
Time frame: At one year, 6 years, 8 years and 10 years of follow-up
Peri-implant health: Bleeding on probing
Time frame: At one year, 6 years, 8 years and 10 years of follow-up.
Peri-implant Health: Plaque
Time frame: at one year, 6 years, 8 years and 10 years of follow-up.
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 28 Jul 2025.
- Results publication: PubMed 30048048Glibert M, Matthys C, Maat RJ, De Bruyn H, Vervaeke S. A randomized controlled clinical trial assessing initial crestal bone remodeling of implants with a different surface roughness. Clin Implant Dent Relat Res. 2018 Oct;20(5):824-828. doi: 10.1111/cid.12652. Epub 2018 Jul 26.
- Individual participant dataSharing planned: No
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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.
Maarten Glibert, DDS, MSc, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-Mouth Placement of an implant with a moderately rough surface (DCC). and Split-Mouth Placement of an implant with a hybrid surface (MSC). in people with Oral Health Quality of Life (OHQoL) Was Assessed and the Effect of Surface Roughness on Crestal Bone Remodelling, run by University Ghent at 1 site in Belgium.
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 2 inclusion and 3 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 28 Jul 2025. 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 Belgium. 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?
The effect of surface roughness on long-term crestal bone remodelling. (time frame: From enrollment until 8 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07087717, which also lists 1 linked publication.
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 28 Jul 2025.