Root Coverage Performance of Restorative Materials in Class V Cavities
Clinical Evaluation of the Root Coverage Performance of Different Restorative Materials in Class V Cavities in Patients With Gingival Recession
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Gingival recession associated with non-carious cervical lesions (NCCLs) is a common clinical condition that may result in dentin hypersensitivity, root caries, and esthetic concerns. When root coverage surgery is indicated, the presence or absence of a cervical restoration and the type of restorative material may influence soft tissue healing and the stability of the surgical outcome. However, evidence regarding the optimal restorative approach before periodontal plastic surgery remains limited.
This prospective randomized controlled clinical trial will compare the clinical performance of different restorative approaches in Class V cervical lesions undergoing root coverage surgery with a subepithelial connective tissue graft. Eligible patients presenting with Cairo RT1 (Miller Class I-II equivalent) gingival recession and Class V cervical defects will be allocated to one of the study groups according to the study protocol. The interventions include restoration with glass ionomer cement, resin composite or no restoration when appropriate.
All participants will receive standardized periodontal treatment before surgery, followed by root coverage surgery using a subepithelial connective tissue graft. Clinical examinations will be performed at baseline and during follow-up to evaluate treatment outcomes.
The primary outcome is the percentage of root coverage achieved after surgery. Secondary outcomes include changes in gingival recession depth, clinical attachment level, keratinized tissue width, probing depth, dentin hypersensitivity, esthetic outcomes, and the clinical stability of the treated sites. The findings will help determine whether the restorative material placed in Class V cervical lesions influences the success of periodontal root coverage procedures.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Zeliha B ÇAKIR ERDİL, DDS
- Telefonnummer: +905059444038
- E-post: bskcakirr@gmail.com
Studer Kontakt Backup
- Navn: Metin Çalışır, Prof.DR
- E-post: metincalisir@adiyaman.edu.tr
Studiesteder
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Merkez
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Adıyaman, Merkez, Tyrkia (Türkiye), 02030
- Rekruttering
- Faculty of Dentistry, Adıyaman University
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Ta kontakt med:
- Zeliha B ÇAKIR ERDİL
- Telefonnummer: 05059444038
- E-post: bskcakirr@gmail.com
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Underetterforsker:
- Zeliha Başak ÇAKIR ERDİL, DDS
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Hovedetterforsker:
- METİN ÇALIŞIR, Prof.Dr.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Adults aged 18 years or older. Patients presenting with Cairo RT1 (Miller Class I or II equivalent) gingival recession defects requiring root coverage surgery.
Presence of a non-carious cervical lesion (NCCL), an existing cervical restoration, or a cervical defect requiring restoration.
Cervical lesion depth of ≤1.5 mm. Patients who have completed initial periodontal therapy before enrollment. Good oral hygiene (Plaque Index ≤20% or as determined by the investigator). Indication for root coverage surgery with a subepithelial connective tissue graft.
Teeth suitable for restoration with glass ionomer cement, resin composite, or flowable resin composite, or requiring no restoration according to the study protocol.
Ability and willingness to provide written informed consent and comply with study visits.
Exclusion Criteria:
- Age younger than 18 years. Pregnancy or breastfeeding. Poor oral hygiene. Uncontrolled systemic disease or any medical condition contraindicating periodontal surgery.
Bleeding disorders or current anticoagulation that contraindicates connective tissue graft harvesting.
Known allergy or hypersensitivity to resin composite, flowable resin composite, glass ionomer cement, or any study materials.
Patients who have not completed initial periodontal therapy. Cervical lesions deeper than 1.5 mm. Conditions that, in the investigator's opinion, could interfere with wound healing, periodontal surgery, or study outcomes.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: No Restoration Control Grou
Participants will be randomly assigned to one of three parallel groups: no restoration control, glass ionomer cement restoration, or resin composite restoration before root coverage surgery.
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No restorative material will be placed in the Class V cervical lesion before root coverage surgery.
Participants will undergo root coverage surgery using a coronally advanced flap with a subepithelial connective tissue graft according to the study protocol.
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Eksperimentell: Glass Ionomer Cement Group
Participants will receive restoration of the Class V cervical lesion with glass ionomer cement before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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Eksperimentell: Resin Composite Group
Participants will receive restoration of the Class V cervical lesion with resin composite before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Root Coverage
Tidsramme: Baseline to 6 months after surgery
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The percentage of root coverage will be evaluated after root coverage surgery in Class V cervical lesions treated with different restorative approaches, including glass ionomer, resin composite, flowable composite, or no restoration.
The outcome will assess which material or approach provides greater soft tissue coverage over the cervical/root surface.
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Baseline to 6 months after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HRU-25.18.53
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