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NCT Number: NCT06305000

Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:

Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?

Our study consists of 4 groups:

Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.

Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year
  • No systemic disease and medication use that may affect periodontal or peri-implanter tissues
  • Not receiving periodontal treatment in the last 6 months
  • Volunteering to participate in the study

Exclusion criteria

  • Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement
  • Being pregnant or breastfeeding,
  • Autoimmune and/or inflammatory diseases of the oral cavity,
  • Active periodontal disease
  • Smokers (≥ 10 cigarettes per day)
  • Improperly positioned implants

Treatment and study plan

Non-surgical treatment

Procedure

Non-surgical treatment consists of oral hygiene instructions, full mouth supragingival scaling using titanium hand instruments, ultrasonic devices, and subgingival debridement under local anesthesia with titanium curettes and ultrasonic instruments in a single appointment.

Free gingival graft

Procedure

After adequate local anesthesia is achieved. A horizontal incision is placed mucogingival junction level to prepare the recipient bed. A split-thickness flap is raised without disturbing the periosteum. FGG is obtained from the palate, extending from the mesial surface of the second premolar to the middle of the first molar. The graft is shaped and stitched on the recipient surface.

Primary outcomes

  1. Inflammatory parameter levels in peri-implant crevicular fluid

    Time frame: Baseline (prior to therapy)

    Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.

  2. Inflammatory parameter levels in peri-implant crevicular fluid

    Time frame: 1st month

    Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.

  3. Inflammatory parameter levels in peri-implant crevicular fluid

    Time frame: 4th month

    Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.

  4. Inflammatory parameter levels in peri-implant crevicular fluid

    Time frame: 7th month

    Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.

Secondary outcomes

  1. Plaque index (Silness & Löe, 1964)

    Time frame: Baseline (prior to therapy)

    0: Absence of microbial plaque

    • Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
    • Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
    • Abundant plaque along with the mucosal margin; interdental places filled with plaque

  2. Plaque index (Silness & Löe, 1964)

    Time frame: 1st month

    Plaque index (Silness & Löe, 1964):

    0: Absence of microbial plaque

    • Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
    • Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
    • Abundant plaque along with the mucosal margin; interdental places filled with plaque

  3. Plaque index (Silness & Löe, 1964)

    Time frame: 4th month

    0: Absence of microbial plaque

    • Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
    • Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
    • Abundant plaque along with the mucosal margin; interdental places filled with plaque

  4. Plaque index (Silness & Löe, 1964)

    Time frame: 7th month

    0: Absence of microbial plaque

    • Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
    • Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
    • Abundant plaque along with the mucosal margin; interdental places filled with plaque

  5. Gingival Index ( Löe & Silness,1963)

    Time frame: Baseline (prior to therapy)

    0: normal gingiva

    • mild inflammation - slight change in color and slight edema but no bleeding on probing
    • moderate inflammation - redness, edema and glazing, bleeding on probing
    • severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  6. Gingival Index ( Löe & Silness,1963)

    Time frame: 1st month

    0: normal gingiva

    • mild inflammation - slight change in color and slight edema but no bleeding on probing
    • moderate inflammation - redness, edema and glazing, bleeding on probing
    • severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  7. Gingival Index ( Löe & Silness,1963)

    Time frame: 4th month

    0: normal gingiva

    • mild inflammation - slight change in color and slight edema but no bleeding on probing
    • moderate inflammation - redness, edema and glazing, bleeding on probing
    • severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  8. Gingival Index ( Löe & Silness,1963)

    Time frame: 7th month

    0: normal gingiva

    • mild inflammation - slight change in color and slight edema but no bleeding on probing
    • moderate inflammation - redness, edema and glazing, bleeding on probing
    • severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  9. Bleeding on probing (Ainamo & Bay 1975)

    Time frame: Baseline (prior to therapy)

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  10. Bleeding on probing (Ainamo & Bay 1975)

    Time frame: 1st month

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  11. Bleeding on probing (Ainamo & Bay 1975)

    Time frame: 4th month

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  12. Bleeding on probing (Ainamo & Bay 1975)

    Time frame: 7th month

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  13. Keratinized mucosa width

    Time frame: Baseline (prior to therapy)

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  14. Keratinized mucosa width

    Time frame: 1st month

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ). Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  15. Keratinized mucosa width

    Time frame: 4th month

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ). Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  16. Keratinized mucosa width

    Time frame: 7th month

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ). Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  17. Probing depth

    Time frame: Baseline (prior to therapy)

    Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  18. Probing depth

    Time frame: 1st month

    Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  19. Probing depth

    Time frame: 4th month

    The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  20. Probing depth

    Time frame: 7th month

    The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

Study contacts

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

Ayse E Selman

CONTACT

[email protected]

+905366393184

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Feb 10, 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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