The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations (DWT)
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations: An 18-Month Randomized Clinical Trial
This randomized clinical trial will evaluate whether the decoupling with time technique improves the clinical performance of Class II posterior composite restorations compared with conventional composite restoration techniques. The study will also assess postoperative hypersensitivity and the additional operative time required to perform the decoupling with time technique. Participants will receive a posterior composite restoration and will be followed for 18 months. Clinical performance will be evaluated using the Modified United States Public Health Service (USPHS) criteria, and postoperative hypersensitivity will be assessed before treatment, 1 week after restoration placement, and at 6, 12, and 18 months. The study will help determine whether the additional time required for the decoupling with time technique is associated with improved clinical outcomes.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This randomized clinical trial will evaluate the effect of the decoupling with time technique on the clinical performance of posterior composite restorations in Class II cavities.
The study will include eligible participants requiring posterior Class II composite restorations. Participants will be randomly allocated to either the decoupling with time group or the conventional restoration group.
In the decoupling with time group, following cavity preparation, immediate dentin sealing will be performed using a universal adhesive system applied with a selective enamel-etching strategy. A conventional flowable resin composite will then be applied as an initial stress-reducing layer with a thickness of approximately 0.5-1.0 mm. A 5-minute waiting period will be allowed before completion of the composite restoration. Deep margin elevation will not be performed as part of the study protocol.
The control group will receive a conventional posterior composite restoration according to the standardized restorative protocol without the decoupling with time waiting period.
The primary outcome will be postoperative hypersensitivity, assessed using the Modified United States Public Health Service (USPHS) criteria. Hypersensitivity will be assessed pre-operatively, at 1 week after restoration placement, and at 6, 12, and 18 months after restoration placement.
The clinical performance of the restorations will be evaluated using the Modified USPHS criteria immediately after restoration placement and at 6, 12, and 18 months. The evaluated clinical parameters will include marginal integrity, fracture and retention, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, and secondary caries.
The total operative time required to complete each restoration will also be recorded in minutes using a digital stopwatch, starting from the beginning of the restorative procedure and ending upon completion of the restoration. This will allow assessment of whether the additional operative time associated with the decoupling with time technique is associated with improved clinical outcomes.
Participants will be followed for 18 months to evaluate the clinical performance of the restorations and postoperative hypersensitivity over time.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Mahetab Mahmoud Abd Elhameed, Master's candidate
- Numer telefonu: 201151895247
- E-mail: mahetab.mahmoud@dentistry.cu.edu.eg
Kopia zapasowa kontaktu do badania
- Nazwa: Omar Shaalan, Assoc. Professor of Conservati
- Numer telefonu: 201122665661
- E-mail: omar.shaalan@dentistry.cu.edu.eg
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patients aged between 20 and 40 years.
- Patients with posterior carious Class II lesions.
- Good oral hygiene.
- Favorable occlusion.
- Absence of deleterious oral habits.
Exclusion Criteria:
- Teeth showing signs of irreversible pulpitis.
- Teeth with secondary caries.
- Teeth with old restorations.
- Endodontically treated teeth.
- Patients with a history of adverse reactions to the test material.
- Patients with poor oral hygiene.
- Patients with systemic disease.
- Patients with severe periodontal disease.
- Uncooperative patients.
- Patients unable to attend the scheduled recall visits.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Decoupling With Time Group
Participants assigned to this group will receive a Class II posterior composite restoration using the decoupling with time technique. Immediate dentin sealing will be performed using a universal adhesive system with a selective enamel-etching strategy, followed by application of a 0.5-1.0 mm layer of conventional flowable resin composite. A 5-minute waiting period will be allowed before completion of the composite restoration. |
Immediate dentin sealing using a universal adhesive system with a selective enamel-etching strategy, followed by application of a 0.5-1.0 mm layer of conventional flowable resin composite and a 5-minute waiting period before completion of the posterior composite restoration. |
|
Aktywny komparator: Conventional Composite Group
Participants assigned to this group will receive a conventional Class II posterior composite restoration without the decoupling with time procedure or the additional 5-minute waiting period. |
Conventional Class II posterior composite restoration without the decoupling with time procedure. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Hypersensitivity
Ramy czasowe: Pre-operatively, 1 week, 6 months, 12 months, and 18 months after restoration placement.
|
Postoperative hypersensitivity will be assessed clinically using the Modified United States Public Health Service (USPHS) criteria. The assessment will be performed before the restorative procedure and at the specified follow-up visits after restoration placement. |
Pre-operatively, 1 week, 6 months, 12 months, and 18 months after restoration placement.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Clinical Performance of Posterior Composite Restorations
Ramy czasowe: Immediately after restoration placement, 6 months, 12 months, and 18 months after restoration placement.
|
Clinical performance of the restorations will be evaluated using the Modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal integrity, fracture and retention, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, and secondary caries. |
Immediately after restoration placement, 6 months, 12 months, and 18 months after restoration placement.
|
|
Total Operative Time
Ramy czasowe: During the restorative procedure.
|
The total time required to complete each restorative procedure will be measured in minutes using a digital stopwatch, starting from the beginning of the restorative procedure and ending upon completion of the restoration. |
During the restorative procedure.
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
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
Inne numery identyfikacyjne badania
- Cons-DWT-C.Perf-2026
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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