- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07924787
Clinician- vs. Patient-Reported Esthetic Outcomes After Coronally Advanced Flap
Comparison of Clinician- and Patient-Reported Esthetic Outcomes Following Coronally Advanced Flap Procedures for the Treatment of Gingival Recession
This study aims to evaluate the relationship between clinician-assessed esthetic outcomes, measured using the Root Coverage Esthetic Score, and patient-reported esthetic outcomes, recorded on a Visual Analog Scale, at 6 months following the treatment of Cairo Recession Type 1 and Type 2 gingival recessions with a coronally advanced flap, combined with a connective tissue graft where clinically indicated.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
In this prospective clinical study, patients who apply to our clinic due to the esthetic complaint or dentin sensitivity will be included. After initial periodontal treatment, patients who meet the criteria will have a coronally positioned flap applied under local anesthesia. In areas where the keratinized tissue width is 2 mm or more and the keratinized tissue thickness is more than 1 mm, a coronally positioned flap will be applied alone. In areas where the keratinized tissue width is less than 2 mm and/or the keratinized tissue thickness is 1 mm or less, a connective tissue graft will be applied in addition to the coronally positioned flap. Clinician and patient results will be compared in the esthetic evaluations to be performed six months after the surgical procedure.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ezgi Gürbüz, DDS PhD
- Telefonnummer: +905557411860
- E-post: ezgi.dogan@ksbu.edu.tr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Systemically healthy individuals
- Individuals over 18 years of age
- Individuals who do not smoke and/or consume alcohol
- Individuals without active periodontitis
- Individuals with full-mouth plaque and bleeding scores of less than 15%
- Presence of single or multiple gingival recessions in the maxilla or mandible
- The affected tooth must be single-rooted
- Presence of Cairo classification Type 1 or Type 2 gingival recession on the buccal surface of the tooth
- A recession depth of at least 2 mm
Exclusion Criteria:
- Individuals with uncontrolled systemic diseases
- Women who are pregnant or breastfeeding
- Individuals who smoke and/or consume alcohol
- Individuals with active periodontitis
- Cases involving tooth rotation or malposition
- Individuals currently undergoing orthodontic treatment
- Gingival recessions associated with teeth that have undergone endodontic treatment or require restorations
- Teeth with dental caries
- Gingival recessions with non-carious cervical lesions that have a horizontal depth (step depth) greater than 1 mm
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Coronally advanced flap procedure
Coronally advanced flap procedure for Cairo type 1 or 2 gingival recession sites |
Patients will have a coronally positioned flap applied under local anesthesia. In areas where the keratinized tissue width is 2 mm or more and the keratinized tissue thickness is more than 1 mm, a coronally positioned flap will be applied alone. In areas where the keratinized tissue width is less than 2 mm and/or the keratinized tissue thickness is 1 mm or less, a connective tissue graft will be applied in addition to the coronally positioned flap. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Root Coverage Esthetic Score
Tidsram: Post-operative 6th month
|
The Root Coverage Esthetic Score evaluates five variables 6 months following surgery (gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color). |
Post-operative 6th month
|
|
Patient-reported esthetic outcome
Tidsram: Post-operative 6th month
|
Patient-reported esthetic outcome will be measured by the Visual Analog Scale (0 representing the minimum value, and 100 maximum value). |
Post-operative 6th month
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recession depth
Tidsram: Pre-operative and post-operative 6th month
|
The distance between gingival margin and cemento-enamel junction |
Pre-operative and post-operative 6th month
|
|
Keratinized tissue width
Tidsram: Pre-operative and post-operative 6th month
|
The distance between gingival margin and mucogingival junction |
Pre-operative and post-operative 6th month
|
|
Keratinized tissue thickness
Tidsram: Pre-operative and post-operative 6th month
|
The thickness measured 1.5 mm apical to the gingival margin |
Pre-operative and post-operative 6th month
|
|
Vestibular depth
Tidsram: Pre-operative and post-operative 6th month
|
The distance between the gingival margin and the greatest concavity at the mucosal fold |
Pre-operative and post-operative 6th month
|
|
Mean root coverage
Tidsram: Post-operative 6th month
|
([Pre-operative Recession Depth - Post-operative Recession Depth] / Pre-operative Recession Depth) × 100 |
Post-operative 6th month
|
|
Linear dimension change
Tidsram: Post-operative 6th month
|
The changes in the horizontal plane measured by superimposition of the STL files |
Post-operative 6th month
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KSBU002
Plan för individuella deltagardata (IPD)
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