Root Coverage Performance of Restorative Materials in Class V Cavities
Clinical Evaluation of the Root Coverage Performance of Different Restorative Materials in Class V Cavities in Patients With Gingival Recession
Przegląd badań
Status
Szczegółowy opis
Gingival recession associated with non-carious cervical lesions (NCCLs) is a common clinical condition that may result in dentin hypersensitivity, root caries, and esthetic concerns. When root coverage surgery is indicated, the presence or absence of a cervical restoration and the type of restorative material may influence soft tissue healing and the stability of the surgical outcome. However, evidence regarding the optimal restorative approach before periodontal plastic surgery remains limited.
This prospective randomized controlled clinical trial will compare the clinical performance of different restorative approaches in Class V cervical lesions undergoing root coverage surgery with a subepithelial connective tissue graft. Eligible patients presenting with Cairo RT1 (Miller Class I-II equivalent) gingival recession and Class V cervical defects will be allocated to one of the study groups according to the study protocol. The interventions include restoration with glass ionomer cement, resin composite or no restoration when appropriate.
All participants will receive standardized periodontal treatment before surgery, followed by root coverage surgery using a subepithelial connective tissue graft. Clinical examinations will be performed at baseline and during follow-up to evaluate treatment outcomes.
The primary outcome is the percentage of root coverage achieved after surgery. Secondary outcomes include changes in gingival recession depth, clinical attachment level, keratinized tissue width, probing depth, dentin hypersensitivity, esthetic outcomes, and the clinical stability of the treated sites. The findings will help determine whether the restorative material placed in Class V cervical lesions influences the success of periodontal root coverage procedures.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Zeliha B ÇAKIR ERDİL, DDS
- Numer telefonu: +905059444038
- E-mail: bskcakirr@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Metin Çalışır, Prof.DR
- E-mail: metincalisir@adiyaman.edu.tr
Lokalizacje studiów
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Merkez
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Adıyaman, Merkez, Turcja (Türkiye), 02030
- Rekrutacyjny
- Faculty of Dentistry, Adıyaman University
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Kontakt:
- Zeliha B ÇAKIR ERDİL
- Numer telefonu: 05059444038
- E-mail: bskcakirr@gmail.com
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Pod-śledczy:
- Zeliha Başak ÇAKIR ERDİL, DDS
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Główny śledczy:
- METİN ÇALIŞIR, Prof.Dr.
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Adults aged 18 years or older. Patients presenting with Cairo RT1 (Miller Class I or II equivalent) gingival recession defects requiring root coverage surgery.
Presence of a non-carious cervical lesion (NCCL), an existing cervical restoration, or a cervical defect requiring restoration.
Cervical lesion depth of ≤1.5 mm. Patients who have completed initial periodontal therapy before enrollment. Good oral hygiene (Plaque Index ≤20% or as determined by the investigator). Indication for root coverage surgery with a subepithelial connective tissue graft.
Teeth suitable for restoration with glass ionomer cement, resin composite, or flowable resin composite, or requiring no restoration according to the study protocol.
Ability and willingness to provide written informed consent and comply with study visits.
Exclusion Criteria:
- Age younger than 18 years. Pregnancy or breastfeeding. Poor oral hygiene. Uncontrolled systemic disease or any medical condition contraindicating periodontal surgery.
Bleeding disorders or current anticoagulation that contraindicates connective tissue graft harvesting.
Known allergy or hypersensitivity to resin composite, flowable resin composite, glass ionomer cement, or any study materials.
Patients who have not completed initial periodontal therapy. Cervical lesions deeper than 1.5 mm. Conditions that, in the investigator's opinion, could interfere with wound healing, periodontal surgery, or study outcomes.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: No Restoration Control Grou
Participants will be randomly assigned to one of three parallel groups: no restoration control, glass ionomer cement restoration, or resin composite restoration before root coverage surgery.
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No restorative material will be placed in the Class V cervical lesion before root coverage surgery.
Participants will undergo root coverage surgery using a coronally advanced flap with a subepithelial connective tissue graft according to the study protocol.
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Eksperymentalny: Glass Ionomer Cement Group
Participants will receive restoration of the Class V cervical lesion with glass ionomer cement before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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Eksperymentalny: Resin Composite Group
Participants will receive restoration of the Class V cervical lesion with resin composite before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Root Coverage
Ramy czasowe: Baseline to 6 months after surgery
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The percentage of root coverage will be evaluated after root coverage surgery in Class V cervical lesions treated with different restorative approaches, including glass ionomer, resin composite, flowable composite, or no restoration.
The outcome will assess which material or approach provides greater soft tissue coverage over the cervical/root surface.
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Baseline to 6 months after surgery
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HRU-25.18.53
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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