Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina in the Esthetic Zone.
3 september 2026 uppdaterad av: Dina Mohamed Hosam Eldin Zaghloul, Mansoura University
Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
This randomized clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone.
A total of 30 patients will be randomly allocated to receive VST using either a biodegradable magnesium membrane or a cortical lamina membrane. Both groups will receive immediate implant placement and xenogeneic bone graft.
The study will compare changes in facial bone dimensions, soft tissue volume, implant stability, pink esthetic score, patient satisfaction, surgical time, and postoperative complications over a 6-month follow-up period.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypten, 35511
- Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
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Kontakt:
- Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery
- Telefonnummer: +201000985501
- E-post: dinahosam90@gmail.com
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Huvudutredare:
- Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery
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Underutredare:
- Nahed Ibrahim Ghoneim, PhD in Oral Surgery
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Underutredare:
- Ayman Moustafa Yaseen, PhD in Oral Surgery
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Underutredare:
- Ammar Taha Kassem, PhD in Prosthodontics
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Age between 18 and 45 years.
- Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets.
- Presence of adequate palatal and apical bone to achieve primary implant stability.
- Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation.
- Good oral hygiene and satisfactory plaque control
Exclusion Criteria:
- Acute infection at the intended implant site (e.g., acute abscess or cellulitis).
- Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration.
- History of irradiation to the head and neck region within one year before implant placement.
- Alcohol or drug abuse.
- Pregnancy or lactation.
- Parafunctional habits such as bruxism or clenching.
- Current smoking or tobacco using.
- Poor oral hygiene or inability to maintain adequate plaque control.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Vestibular Socket Therapy Using Magnesium Membrane
Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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Aktiv komparator: Vestibular Socket Therapy Using Cortical Lamina
Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Facial Bone Dimensional Changes
Tidsram: Immediately after surgery (T0) and 6 months (T6)
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CBCT scans obtained immediately after surgery (T0) and at six months (T6) will be superimposed using OnDemand3D software.
The following parameters will be assessed: facial bone thickness at the crestal level, facial bone thickness at the middle level, facial bone thickness at the apical level, and facial bone height.
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Immediately after surgery (T0) and 6 months (T6)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Soft Tissue Volumetric Changes
Tidsram: Baseline and 6 months postoperatively
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Assessed by superimposition of intraoral scan STL files obtained at baseline and 6 months postoperatively.
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Baseline and 6 months postoperatively
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Patient-reported Esthetic Satisfaction
Tidsram: 6 months postoperatively
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Assessed at 6 months using a 100-mm Visual Analog Scale (VAS), where 0 indicates complete dissatisfaction and 100 indicates complete satisfaction with the esthetic result.
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6 months postoperatively
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Surgical Time
Tidsram: During the surgical procedure
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Recorded in minutes from the start of the surgical procedure until completion.
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During the surgical procedure
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Postoperative Complications
Tidsram: 1 week, 1 month, 3 months, and 6 months postoperatively
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Recorded throughout the follow-up period and evaluated at 1 week, 1 month, 3 months, and 6 months postoperatively for the occurrence of membrane exposure, wound dehiscence, infection, graft loss, and implant failure.
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1 week, 1 month, 3 months, and 6 months postoperatively
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Implant Stability
Tidsram: Immediately postoperatively, 3, and 6 months postoperatively.
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Assessed using radiofrequency analysis (RFA) using an Osstell Mentor Device.
A SmartPeg will be attached to each implant, and resonance frequency measurements will be recorded in four directions (every 90°).
The obtained values will be expressed as Implant Stability Quotient (ISQ) scores, and the mean ISQ value for each implant will be used for statistical analysis.
The Implant Stability Quotient (ISQ) ranges from 1 to 100, with higher scores indicating greater implant stability.
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Immediately postoperatively, 3, and 6 months postoperatively.
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Pink Esthetic Score (PES)
Tidsram: 6 months postoperatively.
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The Pink Esthetic Score (PES) assesses peri-implant soft tissue esthetics using seven parameters, each scored from 0 to 2, for a total score of 0-14.
Higher scores indicate better esthetic outcomes.
Assessed using standardized clinical photographs.
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6 months postoperatively.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Pinto A, Mazzetti V, Carosi P, Lorenzi C. Cortical Laminar Bone Membrane in Implant Dentistry: Biological Basis, Clinical Protocols, and Outcomes. Appl Sci. 2025;15(22):12243.
- Elad A, Rider P, Rogge S, Witte F, Tadic D, Kacarevic ZP, Steigmann L. Application of Biodegradable Magnesium Membrane Shield Technique for Immediate Dentoalveolar Bone Regeneration. Biomedicines. 2023 Mar 1;11(3):744. doi: 10.3390/biomedicines11030744.
- Elaskary A, Thabet A, Hussin M, Radi IA. Soft and hard tissue evaluation for vestibular socket therapy of immediately placed implants in infected and non-infected sockets: a 1-year prospective cohort study. BMC Oral Health. 2024 Oct 7;24(1):1190. doi: 10.1186/s12903-024-04905-3.
- ElAskary A, Elfana A, Meabed M, Abd-ElWahab Radi I, Akram M, Fawzy El-Sayed K. Immediate implant placement utilizing vestibular socket therapy versus early implant placement with contour augmentation for rehabilitation of compromised extraction sockets in the esthetic zone: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Oct;24(5):559-568. doi: 10.1111/cid.13120. Epub 2022 Jul 10.
- Th Elaskary A, Y Gaweesh Y, Maebed MA, Cho SC, El Tantawi M. A Novel Method for Immediate Implant Placement in Defective Fresh Extraction Sites. Int J Oral Maxillofac Implants. 2020 Jul/Aug;35(4):799-807. doi: 10.11607/jomi.8052.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
29 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
29 augusti 2026
Första postat (Faktisk)
2 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- MS.26.08.271
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