Dental ImplantNCT06554444
Assessment of Early Healing Period of Dental Implants
A study testing Dental Implant Surgery in people with Dental Implant and Osseointegration, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Osseointegration, Biological Width
- What is being tested?
- Dental Implant Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 2 Sep 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18
- Systemically healthy
- Need for implant treatment in unilaterally edentulous posterior mandible
- Sufficient interocclusal space for implant and restoration placement
- At least four months passed since tooth extraction
- Alveolar bone height adequate for implant placement, with a minimum width of 6 mm, and without risking anatomical structures
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- Plaque and bleeding scores of less than 15% in the entire mouth
- Presence of opposing teeth in occlusion
- Written informed consent obtained, including permission for the use of data for research purposes
Who cannot join
- Poor oral hygiene
- Uncontrolled periodontal disease
- Pregnancy or lactation at any stage of the study
- Uncontrolled diabetes
- Patients with suppressed immune systems
- History of radiotherapy to the head and neck region
Show all 10Show fewer
- Diseases or medications affecting bone metabolism
- Smoking more than 10 cigarettes per day
- Bone augmentation performed before or concurrently with the implant
- Failure to achieve primary stability with the implant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43020
About this study
Official title: Assessment of Volumetric Changes During the Early Healing Period of Dental Implant Treatment: Clinical, Radiographic, and Digital Evaluation
This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.
- Conditions
- Dental Implant, Osseointegration, Biological Width
- Being tested
- Dental Implant Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant SurgeryProcedure or surgery
Dental implants will be placed in edentulous areas.
| Study group | Role | What they receive |
|---|---|---|
| Dental implant placement in the posterior mandible | Experimental | In this study, patients who have tooth loss in the posterior mandible and meet the inclusion criteria will receive dental implants under local anesthesia Receives: Procedure: Dental Implant Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear and volumetric changes in the tissue
Linear and volumetric changes in the tissue resulting from the alignment of scan data obtained at four different time points.
Measured: Preoperative and postoperative 2nd, 4th, and 16th months
Secondary outcomes (9)
Keratinized mucosa width (from the edentulous ridge)
Keratinized tissue measured from the mid-buccal of the edentulous area using a periodontal probe.
Measured: Preoperative and postoperative 2nd month
Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)
Keratinized tissue measured from the gingival margin of the dental implant-supported prosthesis to the mucogingival junction using a periodontal probe.
Measured: Postoperative 4th and 16th months
Mucosal thickness (from the edentulous ridge)
Mucosal thickness measured from the midpoint of the edentulous area using a periodontal probe.
Measured: Preoperative and postoperative 2nd month
Mucosal thickness (from the facial aspect of the edentulous ridge)
Mucosal thickness measured at the mid-buccal of the edentulous area, from the midpoint between the mucogingival junction and 2 mm apical to the gingival margin of the adjacent tooth, using a endodontic spreader.
Measured: Preoperative and postoperative 2nd month
Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)
Mucosal thickness measured 3 mm apical to the gingival margin of the implant-supported prosthesis using a endodontic spreader.
Measured: Postoperative 4th and 16th months
Peri-implant pocket depth
Peri-implant pocket depth measured at six points around the dental implant using a periodontal probe.
Measured: Postoperative 4th and 16th months
Modified plaque index
Modified plaque index measured at four points around the dental implant using a periodontal probe.
Measured: Postoperative 4th and 16th months
Modified bleeding index
Modified bleeding index measured at four points around the dental implant using a periodontal probe.
Measured: Postoperative 4th and 16th months
Marginal bone level
Marginal bone level measured on periapical radiographs.
Measured: Preoperative and postoperative 2nd, 4th, and 16th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Sep 2024
- Primary completion26 Mar 2026
- Study completion2 Sep 2026
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 Dental ImplantStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dental implant placement in the posterior mandible
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Gürbüz, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554444
- Sponsor's protocol ID
- 05
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tavelli L, Barootchi S, Vera Rodriguez M, Mancini L, Meneghetti PC, Mendonca G, Wang HL. Early soft tissue changes following implant placement with or without soft tissue augmentation using a xenogeneic cross-link collagen scaffold: A volumetric comparative study. J Esthet Restor Dent. 2022 Jan;34(1):181-187. doi: 10.1111/jerd.12856. Epub 2021 Dec 22.
PubMed 34936177
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Volumetric Changes During the Early Healing Period of Dental Implant Treatment: Clinical, Radiographic, and Digital Evaluation
- ClinicalTrials.gov ID
- NCT06554444
- Acronym / sponsor ID
- 05
- Conditions
- Dental Implant, Osseointegration, Biological Width
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 15 Aug 2024 (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 prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dental implant placement in the posterior mandible
| Arm | Type | Receives |
|---|---|---|
| Dental implant placement in the posterior mandible | Experimental | Procedure: Dental Implant SurgeryIn this study, patients who have tooth loss in the posterior mandible and meet the inclusion criteria will receive dental implants under local anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over the age of 18
- Systemically healthy
- Need for implant treatment in unilaterally edentulous posterior mandible
- Sufficient interocclusal space for implant and restoration placement
- At least four months passed since tooth extraction
Key exclusion criteria (10 listed)
- Poor oral hygiene
- Uncontrolled periodontal disease
- Pregnancy or lactation at any stage of the study
- Uncontrolled diabetes
- Patients with suppressed immune systems
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 |
|---|---|---|
| Dental Implant SurgeryDental implants will be placed in edentulous areas. | Procedure or surgery | Dental implant placement in the posterior mandible |
Primary outcome
Linear and volumetric changes in the tissue
Time frame: Preoperative and postoperative 2nd, 4th, and 16th months
Linear and volumetric changes in the tissue resulting from the alignment of scan data obtained at four different time points.
9 secondary outcomes
Keratinized mucosa width (from the edentulous ridge)
Time frame: Preoperative and postoperative 2nd month
Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)
Time frame: Postoperative 4th and 16th months
Mucosal thickness (from the edentulous ridge)
Time frame: Preoperative and postoperative 2nd month
Mucosal thickness (from the facial aspect of the edentulous ridge)
Time frame: Preoperative and postoperative 2nd month
Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)
Time frame: Postoperative 4th and 16th months
Peri-implant pocket depth
Time frame: Postoperative 4th and 16th months
Modified plaque index
Time frame: Postoperative 4th and 16th months
Modified bleeding index
Time frame: Postoperative 4th and 16th months
Marginal bone level
Time frame: Preoperative and postoperative 2nd, 4th, and 16th 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 16 Oct 2026.
- Background: PubMed 34936177Tavelli L, Barootchi S, Vera Rodriguez M, Mancini L, Meneghetti PC, Mendonca G, Wang HL. Early soft tissue changes following implant placement with or without soft tissue augmentation using a xenogeneic cross-link collagen scaffold: A volumetric comparative study. J Esthet Restor Dent. 2022 Jan;34(1):181-187. doi: 10.1111/jerd.12856. Epub 2021 Dec 22.
- 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.
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 Dental Implant Surgery in people with Dental Implant and Osseointegration, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 9 inclusion and 10 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 16 Oct 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 Turkey (Türkiye). 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?
Linear and volumetric changes in the tissue (time frame: Preoperative and postoperative 2nd, 4th, and 16th months). 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 NCT06554444, 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 16 Oct 2026.