Clinical trial NCT06399198: Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
Official title: Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insufficient Keratinized Gingiva
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:

Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?

Our study consists of 2 groups:

The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).

The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).

Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.


Eligibility criteria: Inclusion Criteria:

* Periodontal and peri-implant tissue health
* Good oral hygiene (plaque accumulation \<20%)
* Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery \<2 mm keratinized gingiva on the vestibular side of the implant
* No systemic disease and medication use that may affect soft tissue healing.
* Volunteering to participate in the study

Exclusion Criteria:

* Systemic disease that is a contraindication to the surgical procedure,
* Uncontrolled diabetes (HbA1c \> 7),
* Being pregnant or breastfeeding,
* Autoimmune and/or inflammatory diseases of the oral cavity,
* Active periodontal disease,
* Incorrectly positioned implants

Primary outcomes:
measure: The three-dimensional changes of free gingival graft
timeFrame: Baseline
measure: The three-dimensional changes of free gingival graft.
timeFrame: 1st month
measure: The three-dimensional changes of free gingival graft
timeFrame: 3rd month
measure: The three-dimensional changes of free gingival graft
timeFrame: 6th month
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline
measure: Plaque index
timeFrame: 1st month
measure: Plaque index
timeFrame: 3rd month
measure: Plaque index
timeFrame: 6th month
measure: Gingival Index
timeFrame: Baseline (prior to therapy)
measure: Gingival Index
timeFrame: 1st month
measure: Gingival Index
timeFrame: 3rd month
measure: Gingival Index
timeFrame: 6th month
measure: Bleeding on probing
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: 1st month
measure: Bleeding on probing
timeFrame: 3rd month
measure: Bleeding on probing
timeFrame: 6th month
measure: Keratinized mucosa width
timeFrame: Baseline (prior to therapy)
measure: Keratinized mucosa width
timeFrame: 1st month
measure: Keratinized mucosa width
timeFrame: 3rd month
measure: Keratinized mucosa width
timeFrame: 6th month
measure: Probing depth
timeFrame: Baseline
measure: Probing depth
timeFrame: 1st month
measure: Probing depth
timeFrame: 3rd month
measure: Probing depth
timeFrame: 6th month
measure: Wound healing
timeFrame: 10th day
measure: Wound healing
timeFrame: 1st month
measure: Wound healing
timeFrame: 3rd month
measure: Wound healing
timeFrame: 6th month
measure: Patient reported outcomes
timeFrame: 10th day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References: