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NCT Number: NCT07330609

Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts on 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.

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Key information

Conditions

Peri-Implant Health Free Gingival Graft Peri-implant Mucositis

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, Merkez, 43100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ezgi Gürbüz

CONTACT

[email protected]

+905557411860

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Coronal palatal tissue

Procedure

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 tissue

Procedure

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.

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Keratinized Mucosa Width

    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)

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

  2. Vestibular Depth

    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)

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

  3. Modified Plaque Index

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

    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.

  4. Modified Bleeding Index

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

    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.

  5. Peri- implant Probing Depth

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

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

  6. Mucosal Recession

    Time frame: 12th month after prosthetic loading

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

  7. Marginal Bone Level

    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)

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

  8. Pink Esthetic Score (PES)

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

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

  9. Postoperative Pain Assessment

    Time frame: Postoperative 14 days (daily after graft application)

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

  10. Analgesic Consumption

    Time frame: Postoperative 14.days (after graft application)

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

  11. Patient Satisfaction

    Time frame: Postoperative 14.days (after graft application)

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

  12. Patient-Perceived Esthetic Outcome

    Time frame: 12th month after prosthetic loading

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

  13. Oral Health-Related Quality of Life

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ezgi Gürbüz

CONTACT

[email protected]

+905557411860

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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