Clinical trial NCT06305000: Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
Official title: Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory parameter levels in peri-implant crevicular fluid
timeFrame: Baseline (prior to therapy)
measure: Inflammatory parameter levels in peri-implant crevicular fluid
timeFrame: 1st month
measure: Inflammatory parameter levels in peri-implant crevicular fluid
timeFrame: 4th month
measure: Inflammatory parameter levels in peri-implant crevicular fluid
timeFrame: 7th month
Secondary outcomes:
measure: Plaque index (Silness & Löe, 1964)
timeFrame: Baseline (prior to therapy)
measure: Plaque index (Silness & Löe, 1964)
timeFrame: 1st month
measure: Plaque index (Silness & Löe, 1964)
timeFrame: 4th month
measure: Plaque index (Silness & Löe, 1964)
timeFrame: 7th month
measure: Gingival Index ( Löe & Silness,1963)
timeFrame: Baseline (prior to therapy)
measure: Gingival Index ( Löe & Silness,1963)
timeFrame: 1st month
measure: Gingival Index ( Löe & Silness,1963)
timeFrame: 4th month
measure: Gingival Index ( Löe & Silness,1963)
timeFrame: 7th month
measure: Bleeding on probing (Ainamo & Bay 1975)
timeFrame: Baseline (prior to therapy)
measure: Bleeding on probing (Ainamo & Bay 1975)
timeFrame: 1st month
measure: Bleeding on probing (Ainamo & Bay 1975)
timeFrame: 4th month
measure: Bleeding on probing (Ainamo & Bay 1975)
timeFrame: 7th month
measure: Keratinized mucosa width
timeFrame: Baseline (prior to therapy)
measure: Keratinized mucosa width
timeFrame: 1st month
measure: Keratinized mucosa width
timeFrame: 4th month
measure: Keratinized mucosa width
timeFrame: 7th month
measure: Probing depth
timeFrame: Baseline (prior to therapy)
measure: Probing depth
timeFrame: 1st month
measure: Probing depth
timeFrame: 4th month
measure: Probing depth
timeFrame: 7th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Ayse E Selman
role: PRINCIPAL_INVESTIGATOR
References: