AzTrials
AzTrials

Peri-implant HealthNCT07330609

Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts on Peri-implant Mucosa

A study testing Coronal palatal tissue and Apical palatal tissue in people with Peri-implant Health and Free Gingival Graft, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the effects of autogenous grafts harvested from different palatal regions on the peri-implant mucosa when applied during second-stage dental implant surgery. Read more about this study

Who is it for?
Ages 18 months and older
What is being tested?
Coronal palatal tissue and Apical palatal tissue
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Feb 2026to 1 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age over 18 years
  • Systemically healthy patients
  • Presence of premolar or molar tooth loss in the mandible
  • Adequate mesiodistal and interocclusal space for implant and restoration placement
  • At least four months elapsed since tooth extraction
  • Alveolar bone width of at least 6 mm and sufficient alveolar bone height to allow implant placement without compromising anatomical structures
Show all 12Show fewer
  • Full-mouth plaque and bleeding scores less than 20%
  • Presence of opposing teeth in occlusion
  • Keratinized mucosa width in the relevant region less than 2 mm
  • Keratinized mucosa thickness in the relevant region of 2 mm or less
  • Presence of a healthy second premolar in the maxilla
  • Provision of written informed consent and 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 mellitus
  • Immunocompromised patients
  • Previous radiotherapy to the head and neck region
Show all 11Show fewer
  • Diseases or medications affecting bone metabolism
  • Antibiotic use within the three months prior to the procedure
  • Smoking more than 10 cigarettes per day
  • Pre- or simultaneous bone augmentation prior to implant placement
  • Lack of primary stability at the time of implant placement

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ezgi Gürbüz contact

+905557411860

ezgi.dogan@ksbu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Kutahya Health Sciences University

    Kütahya, Merkez, 43100

    Ezgi Gürbüz, +905557411860, ezgi.dogan@ksbu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts Harvested From Different Palatal Sites and Applied During Second-stage Implant Surgery on the Peri-implant Mucosa

This study aims to evaluate the effects of autogenous grafts harvested from different palatal regions on the peri-implant mucosa when applied during second-stage dental implant surgery.

Clinical, radiographic, and digital assessment methods will be used to investigate the early effects of these grafts on peri-implant mucosal width and thickness. In addition, peri-implant tissue health and patient-reported outcomes will be evaluated to compare the effectiveness of the grafting techniques in peri-implant soft tissue management.

Being tested
Coronal palatal tissue, Apical palatal tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronal palatal tissueProcedure or surgery

    This group will receive palatal grafts including marginal and interdental gingiva. This coronal palatal tissue will be applied to the peri-implant tissue at the second-stage implant surgery.

  • Apical palatal tissueProcedure or surgery

    This group will receive palatal grafts harvested from approximately 1.5 mm apical to the gingival margin. This graft will be applied to the peri-implant tissue at the second-stage implant surgery.

Study groups in NCT07330609
Study groupRoleWhat they receive
Coronal palatal tissueExperimentalParticipants in this group will receive grafts including marginal and interdental palatal gingiva.
Receives: Procedure: Coronal palatal tissue
Apical palatal tissueActive comparatorParticipants in this group will receive grafts harvested from approximately 1.5 mm apical to the palatal gingival margin.
Receives: Procedure: Apical palatal tissue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peri-implant Mucosal Thickness

    The primary outcome is the change in peri-implant mucosal thickness measured at four time points using clinical and digital methods.

    Measured: Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

Secondary outcomes (13)

  1. Keratinized Mucosa Width

    Keratinized tissue width will be measured from the mid-buccal aspect of the edentulous area.

    Measured: Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

  2. Vestibular Depth

    Vestibular depth is defined as the vertical distance between the midcrestal area and the point of greatest concavity of the mucosal fold.

    Measured: Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

  3. Modified Plaque Index

    Modified plaque index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3.

    Measured: Postoperative 6th month after implant placement and 12th month after prosthetic loading

  4. Modified Bleeding Index

    Modified bleeding index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3.

    Measured: Postoperative 6th month after implant placement and 12th month after prosthetic loading

  5. Peri- implant Probing Depth

    Peri-implant probing depth will be measured at six points around each implant.

    Measured: Postoperative 6th month after implant placement and 12th month after prosthetic loading

  6. Mucosal Recession

    Mucosal recession will be measured as the distance between the implant abutment interface and the mucosal margin.

    Measured: 12th month after prosthetic loading

  7. Marginal Bone Level

    Marginal bone level will be measured on periapical radiographs taken by the parallel technique.

    Measured: Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

  8. Pink Esthetic Score (PES)

    Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score with a minimum value of 0 and a maximum of 14.

    Measured: Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading

  9. Postoperative Pain Assessment

    Postoperative pain as patient-reported outcome will be recorded using a visual analog scale (VAS; 0-100).

    Measured: Postoperative 14 days (daily after graft application)

  10. Analgesic Consumption

    The amount of analgesic medication used (mg) will be recorded.

    Measured: Postoperative 14.days (after graft application)

  11. Patient Satisfaction

    Patient satisfaction with the surgical procedure will be assessed using a three-point Likert scale (0 = no, 1 = maybe, 2 = yes).

    Measured: Postoperative 14.days (after graft application)

  12. Patient-Perceived Esthetic Outcome

    Patient perception of peri-implant soft tissue esthetics will be evaluated using a visual analog scale (VAS; 0-100).

    Measured: 12th month after prosthetic loading

  13. Oral Health-Related Quality of Life

    Oral health-related quality of life will be assessed using the Oral Health Impact Profile (OHIP-14) questionnaire.

    Measured: Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study start2 Feb 2026
  3. Primary completion2 Aug 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

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
Randomized controlled clinical trial with parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07330609
Sponsor's protocol ID
KSBU001
Status last verified
Dec 2025
First submitted
29 Dec 2025
Last updated
28 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zigdon H, Machtei EE. The dimensions of keratinized mucosa around implants affect clinical and immunological parameters. Clin Oral Implants Res. 2008 Apr;19(4):387-92. doi: 10.1111/j.1600-0501.2007.01492.x. Epub 2008 Feb 11.

    PubMed 18266873

  • Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation procedures at second-stage surgery: a systematic review. Clin Oral Investig. 2016 Sep;20(7):1369-87. doi: 10.1007/s00784-016-1815-2. Epub 2016 Apr 4.

    PubMed 27041111

Questions about this trial

What is this clinical trial studying?

A study testing Coronal palatal tissue and Apical palatal tissue in people with Peri-implant Health and Free Gingival Graft, 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 12 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ezgi Gürbüz (+905557411860, ezgi.dogan@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-implant Mucosal Thickness (time frame: Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)). 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 NCT07330609, which also lists 2 linked publications.

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 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in