- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07836920
Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth
Clinical Evaluation of the Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth: A Randomized Clinical Trial
This study compares two methods of restoring posterior teeth after root canal treatment. Traditionally, dentists use fiber posts and full coverage crowns, but this requires removing more tooth structure, which can weaken teeth further. A newer, more conservative option is the overlay, which preserves more of the natural tooth. While overlays appear promising, evidence is still limited, particularly for posterior teeth.
The trial, conducted at Cairo University, will involve fifty patients aged 20-50 with properly root canal treated posterior teeth. Participants will be randomly divided into two groups: one receiving a fiber-reinforced composite with a lithium disilicate overlay (conservative method), and the other receiving a fiber post, composite core, and full coverage lithium disilicate crown (conventional method).
The primary outcome will be tooth integrity after six months, evaluated with standardized criteria. Secondary outcomes include margin quality, discoloration, secondary decay, color matching, and patient satisfaction. Patients will be blinded to the treatment they receive, and data will be analyzed using appropriate statistical methods.
Studieoversigt
Status
Detaljeret beskrivelse
This research protocol explores two different ways of restoring posterior teeth after root canal treatment. Teeth that have had root canal treatment often become weaker because part of their natural structure is removed, and the dentin itself becomes more fragile. As a result, these teeth are more likely to break. Dentists have usually treated this problem by placing a fiber post inside the root canal and then covering the tooth with a full coverage crown. This method has worked well, but it involves drilling inside the root canal, which can make the tooth weaker on the long run.
With advances in modern dentistry, new techniques aim to be more conservative; they try to save as much of the natural tooth as possible. One of these approaches is the overlay, a type of partial coverage restoration that seats on top of the tooth but does not require as much removal of healthy structure as a full coverage crown. Recent studies suggest that overlays can perform just as well as crowns, but there is still not enough strong clinical evidence to confirm this for all cases, especially for posterior teeth that face heavy biting forces. This trial will help fill that gap in the literature.
The study will take place at the Faculty of Dentistry, Cairo University, and will include fifty patients aged between 20 and 50 years. All patients must have had root canal treatment on a restorable posterior tooth. Those with poorly treated canals, cracked teeth, gum disease, or bruxism will not be included. Patients who join the trial will be divided randomly into two groups. One group will receive the conservative approach: the cavity will be filled with fiber-reinforced composite, and the tooth will be prepared for a lithium disilicate overlay. The other group will follow the conventional method: a fiber post will be placed, a composite build-up added, and finally the tooth will be covered with a full coverage lithium disilicate crown.
The main goal is to see how well each method keeps the tooth intact after six months, using a standard set of criteria to judge success. Other factors will also be checked, such as how well the margins fit, whether there is discoloration or secondary decay, and whether the color matches the surrounding teeth. Importantly, patients will also be asked how satisfied they are with the treatment, using a simple scale to record their feelings.
To make sure the study is fair, patients will be randomly assigned to one of the two groups using a computer program. The operator performing the treatment will know which method is being used, but the patients and the statistician analyzing the results will not, which helps reduce bias. Data will be collected carefully and stored securely. Standard statistical methods will be used to analyze the results, with differences considered significant if the probability of chance is 5% or less.
All patients will sign a consent before joining. Any possible side effects, such as minor discomfort, will be noted. After the six-month follow-up, results will be published in scientific journals and conferences.
By comparing these two approaches, the study hopes to show whether the conservative overlay technique can be a reliable alternative to the traditional crown. If proven successful, this method could help dentists save more of the natural tooth structure, reduce treatment time, and still provide durable, esthetic, and satisfying results for patients.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Moataz M Anwar, MSC
- Telefonnummer: +201000395041
- E-mail: moataz.mostafa@dentistry.cu.edu.eg
Undersøgelse Kontakt Backup
- Navn: Reham S Elbasty, MSC, PhD
- Telefonnummer: +201207169671
- E-mail: reham.elbasty@dentistry.cu.edu.eg
Studiesteder
-
-
Manial
-
Cairo, Manial, Egypten
- Rekruttering
- Faculty of Dentistry, Cairo University
-
Kontakt:
- Reham S Elbasty, MSC, PhD
- Telefonnummer: +201207169671
- E-mail: reham.elbasty@dentistry.cu.edu.eg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients 20-50 years of age
- Root canal treated posterior teeth
- Good C/R ratio
- Good quality root canal treatment (adequate working length, absence of post operative complications or pain and adequate follow up period)
- Presence of adequate labial and palatal wall thickness
- Natural antagonist teeth
- Natural adjacent teeth
Exclusion Criteria:
- Improper root canal treatment
- Post operative complications.
- Cracked teeth
- Parafunctional habits (bruxism)
- Wear pattern
- Pregnancy for females
- Opposing prosthetics
- Presence of periodontal disease
- Severely destructed posterior teeth
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Fiber reinforced composite core and lithium disilicate overlay
This arm implements a restorative approach that combines the mechanical support of a fiber-reinforced composite (FRC) core with the esthetic and durable properties of a lithium disilicate overlay. The FRC core provides internal reinforcement, distributing stresses within the tooth and enhancing fracture resistance, while the lithium disilicate overlay offers high strength, wear resistance, and excellent optical qualities. |
This intervention implements a restorative approach that combines the mechanical support of a fiber-reinforced composite (FRC) core with the esthetic and durable properties of a lithium disilicate overlay. The FRC core provides internal reinforcement, distributing stresses within the tooth and enhancing fracture resistance, while the lithium disilicate overlay offers high strength, wear resistance, and excellent optical qualities. |
|
Andet: Fiber post with composite core build up and lithium disilicate full coverage crown
This arm combines the intraradicular retention of a fiber post with a composite core build-up, providing internal support and reinforcement for compromised teeth. The restoration is completed with a lithium disilicate full coverage crown, offering high strength, durability, and excellent esthetics. |
This combines the intraradicular retention of a fiber post with a composite core build-up, providing internal support and reinforcement for compromised teeth. The restoration is completed with a lithium disilicate full coverage crown, offering high strength, durability, and excellent esthetics. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
clinical evaluation of tooth integrity
Tidsramme: 6 months
|
Clinical evaluation of tooth integrity will be measured according to the modified USPHS Criteria having scores of either Alpha, Bravo or Charlie. This will be repeated during the time frame of the Study. |
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient satisfaction
Tidsramme: 6 months
|
This outcome will be measured through handing the participants a questionnaire addressing the function, color and overall quality and acceptance of the final restorations. |
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Zarow M, Vadini M, Chojnacka-Brozek A, Szczeklik K, Milewski G, Biferi V, D'Arcangelo C, De Angelis F. Effect of Fiber Posts on Stress Distribution of Endodontically Treated Upper Premolars: Finite Element Analysis. Nanomaterials (Basel). 2020 Aug 29;10(9):1708. doi: 10.3390/nano10091708.
- Zarow M, Ramirez-Sebastia A, Paolone G, de Ribot Porta J, Mora J, Espona J, Duran-Sindreu F, Roig M. A new classification system for the restoration of root filled teeth. Int Endod J. 2018 Mar;51(3):318-334. doi: 10.1111/iej.12847. Epub 2017 Sep 25.
- Iaculli F, Rengo C, Lodato V, Patini R, Spagnuolo G, Rengo S. Fracture resistance of endodontically-treated maxillary premolars restored with different type of posts and direct composite reconstructions: A systematic review and meta-analysis of in vitro studies. Dent Mater. 2021 Sep;37(9):e455-e484. doi: 10.1016/j.dental.2021.06.007. Epub 2021 Jun 18.
- Ferrari M, Ferrari Cagidiaco E, Goracci C, Sorrentino R, Zarone F, Grandini S, Joda T. Posterior partial crowns out of lithium disilicate (LS2) with or without posts: A randomized controlled prospective clinical trial with a 3-year follow up. J Dent. 2019 Apr;83:12-17. doi: 10.1016/j.jdent.2019.01.004. Epub 2019 Feb 1.
- Abdel-Maksoud HB, Eid BM, Hamdy M, Abdelaal HM. Optimizing fracture resistance of endodontically treated maxillary premolars restored with preheated thermos-viscous composite post-thermocycling, a comparative study. Part I. BMC Oral Health. 2024 Mar 2;24(1):295. doi: 10.1186/s12903-024-03959-7.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2972025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .