Wound Heal Clinical Trial
Official title:
Comparison Of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty In Terms Of Wound Healing And Vestibular Depth Gain
NCT number | NCT05252260 |
Other study ID # | 2018/120 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | June 23, 2020 |
Verified date | February 2022 |
Source | Abant Izzet Baysal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique
Status | Completed |
Enrollment | 52 |
Est. completion date | June 23, 2020 |
Est. primary completion date | June 7, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients were> 18 years old and of both genders, - Patients presenting inadequate vestibular depth and insufficient attached gingiva on incisors in the mandibular anterior region - Full mouth plaque index (PI) and gingival index (GI) scores < 1 - The patients had to be systemically healthy and nonsmokers Exclusion Criteria: - Patients who had Miller class II and more advanced gingival recession in the region of the lower anterior incisors and interproximal attachment loss - Patients who were taking medications that would interfere with the wound-healing process, pregnant or lactating women, - Patients who had previously undergone periodontal surgery in the study area, who had orthodontic therapy and using fixed/removable dentures involving lower anterior teeth were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology | Bolu |
Lead Sponsor | Collaborator |
---|---|
Abant Izzet Baysal University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Wound Healing Scores of the surgical area | The healing of the surgical area was scored by using an index determined by Landry et al and compared between the groups in the evaluated time periods (1:worst and 5:excellent) | Wound healing scores on 3rd day, Wound healing scores on 7th day; Wound healing scores on 14th day; Wound healing scores on 28th day | |
Other | Pain and Loss of Function Scores of the study participants | Patients were asked to rate their postoperative pain and functional changes (discomfort during eating and speaking) on visual analog scales (VAS) and compared between the groups in the evaluated time periods (1: minimum and 10: maximum). Minimum scores mean better results. | Pain and Loss of Function on 1st day; Pain and Loss of Function on 7th day after the operation | |
Other | Change in horizontal wound dimension in the surgical area | The linear dimensions of the wound in the horizontal direction were measured with a digital caliper over the projection on the endodontic file and recorded on the patient form. | Change from Baseline horizontal dimension at 1 week; Change from Baseline horizontal dimension at 2 week; Change from Baseline horizontal dimension at 4 week | |
Other | Scar Tissue Formation Scores in the surgical area | The scar tissue in the operation area was evaluated clinically and compared between the study groups (0: minimum scar formation; 8 maximum scar formation) minimum scar formation is better | Scar Tissue Formation at 1st month | |
Primary | Vestibule Depth Measurement Change (millimeter) | Measurements were performed with the help of a plastic stopper placed on the endodontic canal instrument, with reference to the guides created on the acrylic stent which was prepared before the surgery | Change from Baseline vestibule depth measurement at 1 week; Change from Baseline vestibule depth measurement at 2 week; Change from Baseline vestibule depth measurement at 1 month | |
Secondary | Re-epithelization Area of the operation region | Areas where there is little or no gingival epithelium were evaluated by applying a plaque staining agent to the surgical area. Clinical photographs of the stained gingiva were taken immediately after the operation and on the 3rd, 7th, and 14th days after the operation, using pre-prepared acrylic stents. Images were taken at standard magnification and distance on a digital camera (four optical zooms, 20cm) and the head of each patient was positioned to standardize the images. Incomplete epithelialized areas were measured using an image analysis software by the investigator blinded to the groups | Change from baseline re-epithelization Area at 3 day; Change from baseline re-epithelization Area at 7 day; Change from baseline re-epithelization Area at 14 day |
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