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The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations (DWT)

30 oktober 2026 bijgewerkt door: Mahetab Mahmoud, Cairo University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Decoupling With Time Technique

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.
Actieve vergelijker: 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.
Procedure: Conventional Composite Restoration

Conventional Class II posterior composite restoration without the decoupling with time procedure.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Hypersensitivity
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical Performance of Posterior Composite Restorations
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Cairo University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

30 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • Cons-DWT-C.Perf-2026

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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