Selective versus stepwise removal of deep carious lesions in permanent teeth: a randomised controlled trial from Egypt-an interim analysis

OBJECTIVES: To compare the success, survival and costs of selective versus stepwise carious tissue removal (SE/SW) in permanent teeth with deep (>2/3 dentine depth) carious lesions. DESIGN: Randomised controlled, unicentre, clustered two-arm superiority trial. SETTING: Outpatient clinic of a private university in Cairo, Egypt. PARTICIPANTS: One hundred and fifteen participants (n=132 teeth), aged 18-47 years, from Cairo, Egypt, were enrolled. Premolars/molars with occlusal/occlusal-proximal deep lesions (radiographically >2/3 dentine), sensible pulps, without spontaneous pain, were included. INTERVENTIONS: Peripheral carious tissue removal to hard dentine was performed. Pulpo-proximally, soft dentine was left. A glass ionomer (GI) restoration was placed. After 3-4 months, teeth were randomly allocated to SE (n=66), with reduction of the GI into a base and no further tissue removal, followed by a composite resin restoration, or SW (n=66), with full removal of the GI, additional excavation until firm dentine pulpo-proximally, followed by a GI-based composite restoration. Mean follow-up was 1 year. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was success (absence of endodontic/restorative complications). Secondary outcomes were tooth survival and initial and total treatment costs. RESULTS: Zero/five pulp exposures occurred during SE/SW, and seven/five SE/SW teeth required endodontic therapy. Success after 12 months was 89.4% for SE and 84.9% for SW. The estimated mean time free of complications was 23 and 18 months for SE and SW, respectively, without significant differences between SE and SW (p>0.05/Cox). Initial treatment costs were significantly higher for SW (mean (SD): 507.5 (123.4) Egyptian pounds (EGP)) than SE (mean (SD): 456.6 (98.3) EGP), while total costs showed no significant difference (p>0.05). CONCLUSION: Within the limitations of this interim analysis, and considering the depth of these lesions (>2/3 dentine), SE and SW showed similar risk of failure and overall costs after 1 year

Dvanaestomjesečna klinička procjena: debeloslojni kompozit ojačan vlaknima u usporedbi sa slojevito apliciranim nanohibridnim kompozitom za restauraciju dubokih aproksimalnih lezija na trajnim kutnjacima – randomizirano kontrolirano istraživanje

Objective: The present clinical trial was conducted to evaluate the clinical performance of the biomimetic, bilayered structure utilizing a fiber reinforced bulk fill resin composite with a nanohybrid capping layer, compared to incremental packing of nanohybrid resin composite, in deep proximal cavities in permanent molars. Materials and methods: A total of 36 deep proximal cavities in vital molars were restored either with a bilayered structure of fiber reinforced composite resin as a dentine substitute and a capping layer of nanohybrid composite resin (n=18) or conventional, nanohybrid composite resin incrementation (n=18). The restorations were assessed over a period of 12 months using the modified USPHS criteria. The criteria evaluated were: fracture and retention, marginal integrity, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, postoperative sensitivity and secondary caries. Results: There was no statistically or clinically significant difference between fiber-reinforced resin composite and conventional incremental resin composite. There was no risk for failure regarding all the evaluated modified USPHS criteria for both materials after 12 months (RR= 1(95% CI 0.0209 to 47.8503; P =1.0000)). Conclusion: The biomimetic approach utilizing a fiber reinforced resin composite dentine substitute showed a comparable clinical performance to nanohybrid resin composite incrementation. Bulk fill fiber reinforced resin composite is an efficient alternative in restoration of deep proximal cavities in posterior teeth. Further long term studies are necessary to confirm these results.Svrha rada: Ovo kliničko istraživanje provedeno je da bi se procijenila klinička učinkovitost biomimetičke, dvoslojne strukture debeloslojnoga kompozita ojačanoga vlaknima s nanohibridnim pokrovnim slojem u usporedbi sa slojevito apliciranom nanohibridnim kompozitom u dubokim aproksimalnim kavitetima trajnih kutnjaka. Materijal i metode: Ukupno 36 dubokih aproksimalnih kaviteta na vitalnim kutnjacima restaurirano je ili dvoslojnom strukturom debeloslojnoga kompozita ojačanoga vlaknima kao zamjenom za dentin i pokrovnim slojem nanohibridnoga kompozita (n = 18), ili konvencionalnim nanohibridnim kompozitnim materijalom (n = 18) ). Korištenjem modificiranih kriterija USPHS-a, restauracije su se procjenjivale tijekom 12 mjeseci. Kriteriji koji su se procjenjivali bili su fraktura i retencija, rubni integritet, rubna diskoloracija, anatomski oblik, aproksimalni kontakt, tekstura površine, radiološka procjena, postoperativna osjetljivost i sekundarni karijes.Rezultati: Nije bilo statistički i klinički značajne razlike između debeloslojnoga kompozita ojačanoga vlaknima i konvencionalnoga kompozita za slojevitu tehniku. Nije bilo rizika od neuspjeha kod svih procijenjenih modificiranih kriterija USPHS-a za oba materijala nakon 12 mjeseci (RR = 1 (95 % CI 0,0209 do 47,8503; P =1,0000). Zaključak: Biomimetički pristup u kojemu se primjenjuje tehnika nadomještanja dentina debeloslojnim kompozitom ojačanim vlaknima pokazao je kliničku učinkovitost usporedivu sa slojevitom aplikacijom nanohibridne kompozitne smole. Debeloslojni kompoziti ojačani vlaknima učinkovita su alternativa u restauraciji dubokih aproksimalnih kaviteta stražnjih zuba, no za potvrdu tih rezultata potrebna su daljnja dugoročna istraživanja