ClinicalTrials.gg
CompletedNCT07934576Updated Nov 13, 2026

Radiographic Bone Height Gain After Osteotome Sinus Floor Elevation With and Without Concentrated Growth Factor

An interventional study of Graft-Free Osteotome Sinus Floor Elevation and CGF-Assisted Osteotome Sinus Floor Elevation in Alveolar Bone Atrophy, sponsored by Ugur Tekin. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Ugur Tekin · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 years 1 month after the study started (first participant enrolled Oct 2017, registered Nov 2026).
Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 33 studies in Alveolar Bone Loss with a site in Turkey — 8 open to participants now, 10 under way, none of them phase 3. Alveolar Bone Loss · Turkey.

Enrollment
17th of 20
13 · median 30
Started
2017
the only one that year
No phase
18 of 33
4 open now
Registered
33rd of 33
by date

Among the 33 studies in Alveolar Bone Loss with a site in Turkey, this one is the 17th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2017, is one of 18 with no phase, and was the 33rd registered.

Alveolar Bone Loss

319 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

Browse Alveolar Bone Loss studies →

Open to participants now

8 of the 33 studies in Alveolar Bone Loss with a site in Turkey are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 47 Alveolar Bone Loss studies recruiting now, 19 (40%) set no upper age limit and 22 (47%) stop at 75 or younger; 4 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This randomized, split-mouth pilot clinical trial investigated whether the application of concentrated growth factor (CGF) improves radiographic bone height gain following osteotome sinus floor elevation during dental implant placement.

Thirteen patients requiring dental implant placement and internal sinus floor elevation in the posterior maxilla were included. In each patient, two implant sites were randomly assigned using a coin-flip method. At the test site, CGF prepared from the patient's own blood was placed between the dental implant and the elevated sinus membrane. At the control site, the corresponding space was left unfilled.

Cone-beam computed tomography (CBCT) scans were obtained before surgery and six months postoperatively. Radiographic bone height gain was calculated as the difference between postoperative and preoperative bone height. Measurements were performed by an examiner blinded to treatment allocation.

The study aimed to compare bone height gain between CGF-assisted and graft-free sinus floor elevation within the same patients.

The study was conducted at Ege University Faculty of Dentistry, Türkiye, with approval from the Ethics Committee of Ege University Faculty of Medicine (Decision No. 17-2/2).

Read the detailed description

This pilot randomized clinical trial used a split-mouth design to evaluate the effect of concentrated growth factor (CGF) on radiographic bone height gain following osteotome sinus floor elevation performed during dental implant placement.

Participants and Study Design

Thirteen patients requiring implant-supported prosthetic rehabilitation and internal sinus floor elevation in the posterior maxilla were enrolled. Eligible patients had approximately 3-6 mm of residual alveolar bone height and required at least two dental implants.

In each participant, two implant sites were randomly allocated to the test or control condition using a coin-flip method before surgery. This paired design allowed comparison of the two treatment approaches within the same patient.

Interventions

All procedures were performed by the same experienced surgeon under local anesthesia.

At both implant sites, osteotome-mediated sinus floor elevation was performed through the prepared implant osteotomies, followed by dental implant placement.

At the test site, autologous CGF was placed between the implant and the elevated sinus membrane. At the control site, the corresponding space was left unfilled, without the application of CGF or bone graft material.

CGF was prepared immediately before surgery from venous blood collected into sterile tubes without anticoagulant. The blood samples were centrifuged using a dedicated CGF centrifugation system according to the manufacturer's protocol. The CGF fraction was separated and used during surgery.

Clinical and Radiographic Assessment

Clinical follow-up examinations were scheduled at one week, one month, and six months after surgery.

Cone-beam computed tomography (CBCT) examinations were performed preoperatively and at six months postoperatively using the same imaging system and patient-specific surgical templates.

Vertical bone height was measured at predetermined implant sites using comparable reference points. Measurements were obtained from the vestibular and palatal aspects, parallel to the long axis of the implant. Bone height gain was calculated by subtracting preoperative residual bone height from postoperative bone height.

All radiographic measurements were performed by the same experienced oral radiology specialist, who was blinded to treatment allocation. Each measurement was repeated three times, and the mean value was used for analysis. Measurements were repeated after one week to assess intra-observer reliability.

Statistical Analysis

Statistical analysis was performed using SPSS version 22.0. Normality was assessed using the Shapiro-Wilk test. A two-way repeated-measures analysis of variance was used to evaluate the effects of treatment condition and time on vertical bone height measurements. Paired-samples t-tests or Wilcoxon signed-rank tests were applied when appropriate. Statistical significance was set at p \< 0.05.

No formal a priori sample size calculation was performed because of the pilot nature of the study. The findings were intended to provide preliminary evidence regarding the potential effect of CGF on bone height gain after osteotome sinus floor elevation.

03

Conditions studied

  • Alveolar Bone Atrophy

Browse trials for

Keywords

  • Concentrated Growth Factor
  • Osteotome Sinus Floor Elevation
  • Dental Implants
  • Radiographic Bone Height Gain
  • Split-Mouth Randomized Clinical Trial
  • Cone-Beam Computed Tomography
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older.

Residual alveolar bone height of approximately 3-6 mm in the posterior maxilla.

Requirement for rehabilitation with at least two dental implants.

Indication for internal (osteotome-mediated) sinus floor elevation.

Absence of systemic conditions contraindicating dental implant placement or sinus augmentation.

Non-smokers.

Unilateral or bilateral tooth deficiency in the posterior maxilla.

Tooth extraction performed at least 4 months before surgery at the planned implant sites.

No history of maxillary sinus disease, sinus infection, or previous sinus-related surgery.

Indication for implant-supported fixed prosthetic rehabilitation.

Willingness to participate and provision of written .

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled systemic diseases.

Pregnancy.

Age younger than 18 years.

Documented allergy to any material used in the study.

History of psychiatric disorders.

Pathological or immunological conditions that could impair wound healing or contraindicate dental implant placement or sinus augmentation surgery.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    CGF-Assisted Sinus Floor Elevation

    In this randomized split-mouth study, one implant site in each participant received osteotome sinus floor elevation with autologous concentrated growth factor (CGF) application. CGF was placed between the dental implant and the elevated sinus membrane during surgery.

    Procedure: CGF-Assisted Osteotome Sinus Floor Elevation

  • Active comparator
    Graft-Free Sinus Floor Elevation

    In the paired control implant site of each participant, osteotome sinus floor elevation and dental implant placement were performed without the application of concentrated growth factor or bone graft material. The space beneath the elevated sinus membrane was left unfilled.

    Procedure: Graft-Free Osteotome Sinus Floor Elevation

Interventions

  • ProcedureGraft-Free Osteotome Sinus Floor Elevation

    Osteotome sinus floor elevation and dental implant placement were performed without the application of concentrated growth factor or bone graft material. The space beneath the elevated sinus membrane was left unfilled.

  • ProcedureCGF-Assisted Osteotome Sinus Floor Elevation

    Osteotome sinus floor elevation and dental implant placement were performed with the application of autologous concentrated growth factor (CGF). CGF was prepared from the patient's venous blood using a dedicated centrifugation protocol and placed between the implant and the elevated sinus membrane during surgery.

06

What researchers measure

Primary outcomes

  1. Radiographic Vertical Bone Height Gain (mm)

    Vertical bone height gain was assessed using cone-beam computed tomography (CBCT) at baseline and six months after surgery. Measurements were obtained at predetermined implant sites from the vestibular and palatal aspects, parallel to the long axis of the implant. The mean of these measurements was used to calculate bone height gain by subtracting preoperative residual bone height from the six-month postoperative bone height. Results were expressed in millimeters (mm) and compared between CGF-treated and control sites.

    Time frame: Baseline (preoperative) and 6 months postoperatively

07

Study locations

1 site
  • Ege University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
    Izmir, İzmir 35100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided — The sharing of de-identified individual participant data has not yet been determined. Aggregated study results may be made available from the corresponding author upon reasonable request, subject to applicable ethical and privacy considerations.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jan 2020, 27 months.

Of 168 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 27 months is above that.

Counting every sponsor, half of 168 studies reached it within 18 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2026
First posted
Nov 13, 2026
StartActual
Oct 5, 2017
Primary completionActual
Jan 12, 2020
CompletionActual
Jan 12, 2020
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07934576
Lead sponsor
Ugur Tekin
Responsible party
Ugur Tekin (Professor of Oral and Maxillofacial Surgery, Ege University) — Sponsor-investigator
First posted
Nov 13, 2026
Start date
Oct 5, 2017
Primary completion
Jan 12, 2020
Completion
Jan 12, 2020
Last update
Nov 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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