V-Reverse Suture Technique Compared to Traditional Anchored Sling Suture in Treating Multiple Gingival Recession
Modified Coronally Advanced Tunnel for Root Coverage With Sling Suture VS. V-Reverse Suture: A Slit-Mouth Pilot Study
The goal of this split-mouth pilot study is to study the effect of two different suturing techniques in root coverage using coronally advanced flap tunnel in multiple adjacent recession cases to see which technique will give superior outcomes in term of mean root coverage percentage, and root coverage esthetic score after 3-months.
The main questions it aims to answer are:
- Does a suturing technique gives superior mean root coverage percentage over another?
- Does a suturing technique gives superior root coverage esthetic score?
Researcher will compare between V-reverse suturing technique and anchored sling suture to see which will result in superior mean root coverage percentage, and root coverage esthetic score after 3-months.
Participants will:
- Come in for a first visit to check your gum health, check eligibility and to be provided with scaling and polishing if needed.
- Come in for surgery and clinical measurements.
- Participant will be asked to complete post-operative questionnaire for 14 days.
- Re-evaluated after 1 week and suture removal at 2 weeks.
- Follow-up after 1 and 3 months.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
This split-moth pilot study is designed to assess the comparative effectiveness of V-reverse suturing technique(test) and anchored sling suturing technique (Control) in patients with bilateral multiple adjacent gingival recession. The primary aim of the study is to compare the test and control groups in terms of the obtained mean root coverage (mRC) and Root coverage esthetic score (RES) in 3 months. The secondary aims are to compare the two groups in terms of Complete root coverage (CRC), Keratinized tissue width (KTW), Gingival thickness (GT), Recession depth (REC), Probing depth (PD), and Patient-reported outcomes and satisfaction.
At surgery day (T0) baseline measurements and photographs will be taken for all participants and they will be treated with coronally advanced tunnel with autogenous connective tissue graft harvested from the palate for both sides. Each side will be randomly allocated for either V-reverse suturing technique (test) or anchored sling suturing technique (control) to advance the tunnel coronally. At the end of the surgery postoperative instructions will be delivered to all patients in a written and oral manner, in conjunction with a medical prescription, and post-operative questionnaire to fill for the next 14 days to capture patient-reported experience measures (PREMs).
Participants will be re-evaluated at 1 week and at 2 weeks sutures will be removed.
At (T1) 1 month after surgery the following parameters will be recorded : bleeding on probing (BOP), plaque index (PI), and recession depth.
At (T2) 3 month after surgery the following parameters will be recorded : bleeding on probing (BOP), plaque index (PI), recession depth, probing depth (PD), clinical attachment loss (CAL), gingival thickness (GT), keratinized tissue width (KTW), Root coverage esthetic score (RES), mean root coverage% (mRC%), and complete root coverage(cRC "YES/NO")..
Visual analog scale from 0 - 10 (10- very dissatisfied, 0- very satisfied) at each visit after surgery was taken to assess patients overall satisfaction, and another visual analog scale from 0 - 10 (10- worst pain, 0- no pain) to assess patients perceptions of pain.
Photographs will be taken at each visit, all indices will be recorded by a calibrated examiner, and oral hygiene instructions will be reinforced at each visit.
The trial will be conducted in accordance with the Declaration of Helsinki (2013) and Good Clinical Practice (GCP) guidelines. Approval has been granted by the Institutional Review Board (IRB) of Jordan University of Science and Technology. Written informed consent will be obtained from all participants prior to enrollment. Adverse events will be documented, monitored, and reported according to IRB requirements.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Jordan
-
Irbid, Jordan, Jordánia, 22110
- Jordan University of Science and Technology
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Age ≥ 18 years
- Periodontally and systemically healthy;
- Good plaque control (FMPS < 20%)
- Presence of two quadrants exhibiting multiple (2 or more sites) adjacent RT1 or RT2 gingival recession ≥ 2 mm in at least one site.
- Non-smoker.
Exclusion Criteria:
- Smoking
- Pregnant or lactating women;
- Untreated periodontitis;
- Systemic disorders with compromised healing potential;
- Use of medications (immuno-suppressants, phenytoin, or anything else that might affect soft tissue healing);
- Undergoing radiotherapy;
- History of mucogingival surgery.
- Presence of severe tooth malposition, rotation, or super-eruption.
- Presence of root caries or inadequate prosthetic restorations;
- Persistence of uncorrected gingival trauma from toothbrushing.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Test: V-Reverse Suture
Coronally advanced tunnel with V-reverse suture.
|
The V-reverse suturing technique can be a valid technique for improving graft and flap stability in the midfacial region which is likely the most crucial area that should be firm for achieving complete root coverage following the tunnel approach. The V-reverse suture starts in the palatal aspect, passing below the splinted contact point. Then the needle engages the graft and the flap (from inside to outside) ≈3 mm apical to the soft tissue margin in the mid-facial area. Then the needle passes to the palatal side under the contact point. Then the needle turns one round around the splinted composite (without pinching the soft tissue), and then the knot is performed and tightened over the composite. At the end, the sutures form a V-reverse shape |
|
Aktív összehasonlító: Control: Anchored Sling Suture
Coronally advanced tunnel with anchored sling suture
|
In addition to interrupted sutures, sling sutures have also regularly been applied as a conventional method of suturing to advance periodontal flaps over exposed root surfaces and connect the papillae to the interdental connective tissues, and composite stops where added to provide better stability.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
mean root coverage percentage
Időkeret: 3 months
|
It represents the average percentage of the initial recession depth that has been successfully covered by new gum tissue over a defined period.
|
3 months
|
|
root coverage esthetic score
Időkeret: 3 months
|
(RES) is a, 10-point, five-variable system developed by Cairo et al. (2009) to objectively evaluate the success of gingival recession treatment.
It evaluates root coverage (60% weight, 0-6 points) and four soft tissue parameters: margin contour, tissue texture, junction alignment, and color (40% weight, 1 point each).
|
3 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentage of complete root coverage
Időkeret: 3 months
|
a periodontal surgical outcome where the gingival margin is repositioned to the level of, or coronal to, the cementoenamel junction (CEJ), completely covering previously exposed root surfaces
|
3 months
|
|
change in keratinized tissue width
Időkeret: at baseline and 3 months
|
Measured as the distance from gingival margin to mucogingival junction (MGJ) using a periodontal probe (UNC15).
|
at baseline and 3 months
|
|
change in gingival thickness
Időkeret: at baseline and at 3 months
|
Probe visibility technique was used, by inserting a periodontal probe (UNC15) in mid-facial aspect of the tooth, and thin gingival biotype is defined as ≤ 1mm (visible probe), while thick is > 1mm (invisible probe).
|
at baseline and at 3 months
|
|
change in recession depth
Időkeret: at baseline, 1 month, and 3 months
|
Measured as the distance between the cementoenamel junction (CEJ) and gingival margin using a periodontal probe (UNC15).
|
at baseline, 1 month, and 3 months
|
|
Patient reported experience measures (PREMs)
Időkeret: For 14 days after surgery
|
were assessed using validated translations of the OHIP-14 questionnaire into the native language of all participants.
Patients were instructed to use a postoperative diary for the first 14 days after the surgery to capture patient-reported experience measures (PREMs).
The diary was designed to assess patient recovery in four main areas: post-surgery sequelae, pain and discomfort, oral function, interference with daily activities.
|
For 14 days after surgery
|
|
change in probing depth
Időkeret: at baseline and 3 months
|
Measured as the distance from the gingival margin to the base of the pocket using a periodontal probe (UNC15).
|
at baseline and 3 months
|
|
Patient satisfaction score
Időkeret: day one, 1week, 2weeks, 1 month, 3months after surgery
|
Visual analog scale from 0 - 10 (10- very dissatisfied, 0- very satisfied) at each visit after surgery was taken to assess patients overall satisfaction.
|
day one, 1week, 2weeks, 1 month, 3months after surgery
|
|
Patient perception of pain score
Időkeret: day one, 1 week, 2 weeks following surgery
|
Visual analog scale from 0 - 10 (10- worst pain, 0- no pain) to assess patients perceptions of pain.
|
day one, 1 week, 2 weeks following surgery
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Tanulmányi szék: Reem Abdel-Hafez, Jordan University of Science and Technology
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
- kísérleti tanulmány
- Fogíny recesszió
- gyökérborítás
- íny
- plakk index
- periodontium
- hasított szájú
- íny vastagsága
- teljes gyökérfedés
- keratinizált szövet szélessége
- Bleeding On Probing
- Multiple Adjacent Gingival Recession
- V-reverse suture
- anchored sling suture
- mean root coverage
- root coverage esthetic score
- probing depth
- recession depth
- coronally advanced tunnel
- patient-reported experience measures
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 20240614
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Qualified researchers affiliated with academic institutions, healthcare organizations, or nonprofit research centers will be able to request access to the de-identified individual participant data (IPD) and supporting documents, including the Study Protocol, Statistical Analysis Plan (SAP), and Analytic Code.
Requests for access will be reviewed by the study sponsor or data access committee to ensure appropriate use and ethical standards.
Approved users will receive access via a secure online data repository, after signing a data use agreement that outlines terms of use, privacy protections, and publication rights.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
- CSR
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .