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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Moataz M Anwar, MSC
- Telefonní číslo: +201000395041
- E-mail: moataz.mostafa@dentistry.cu.edu.eg
Studijní záloha kontaktů
- Jméno: Reham S Elbasty, MSC, PhD
- Telefonní číslo: +201207169671
- E-mail: reham.elbasty@dentistry.cu.edu.eg
Studijní místa
-
-
Manial
-
Cairo, Manial, Egypt
- Nábor
- Faculty of Dentistry, Cairo University
-
Kontakt:
- Reham S Elbasty, MSC, PhD
- Telefonní číslo: +201207169671
- E-mail: reham.elbasty@dentistry.cu.edu.eg
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: 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. |
|
Jiný: 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. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
clinical evaluation of tooth integrity
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient satisfaction
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 2972025
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .