Custom-Made PEEK Versus PTFE Membranes in Maxillary Alveolar Ridge Augmentation
Custom-Made Polyether Ether Ketone Membrane Versus Polytetrafluoroethylene Membrane in Maxillary Alveolar Ridge Augmentation: A Randomized Controlled Clinical Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Guided bone regeneration (GBR) is a widely accepted technique used to reconstruct deficient alveolar ridges prior to or in conjunction with dental implant placement. This study is designed to evaluate the clinical and radiographic outcomes of two different non-resorbable barrier membranes in maxillary ridge augmentation: customized polyether ether ketone (PEEK) membranes and polytetrafluoroethylene (PTFE) membranes.
Thirty patients requiring maxillary alveolar ridge augmentation in the esthetic zone will be recruited from the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Patients will be randomly allocated into two groups of equal size. Group A will receive patient-specific 3D-printed PEEK membranes designed using cone beam computed tomography (CBCT) data and computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Group B will receive PTFE membranes stabilized over the grafted site using bone tacks.
In both groups, autogenous bone graft combined with xenogeneic bone substitute will be used for ridge augmentation. Standard surgical protocols will be followed, including flap elevation, recipient site preparation, graft placement, and tension-free primary closure.
Clinical outcomes will be assessed by evaluating soft tissue healing, infection, membrane exposure, and wound dehiscence. Radiographic outcomes will be evaluated using CBCT scans taken immediately postoperatively, at 6 months, and at 12 months. Three-dimensional analysis will be performed using specialized software to measure volumetric bone gain as well as linear horizontal and vertical ridge augmentation.
The study aims to determine whether customized PEEK membranes provide comparable or superior outcomes to PTFE membranes in terms of bone regeneration, stability of augmented volume, and postoperative complications.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Dania Raad, BDS
- Telefonnummer: 00201063498933
- E-post: raaddania7@gmail.com
Studiesteder
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Dakhaliya
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Al Mansurah, Dakhaliya, Egypt, 12345
- Rekruttering
- Dania Raad
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Ta kontakt med:
- Dania Raad, BDS
- Telefonnummer: 00201063498933
- E-post: raaddania7@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Age between 20 and 45 years. Male or female participants. Presence of single or multiple missing teeth associated with vertical alveolar defects (vertical bone height less than 8 mm), horizontal alveolar defects (ridge width less than 6 mm), or combined defects in the maxillary esthetic zone requiring alveolar ridge augmentation before implant placement.
Good oral hygiene.
Exclusion Criteria:
Uncontrolled medical disorders contraindicating surgical intervention. Systemic diseases or medications affecting bone metabolism. Current or previous bisphosphonate therapy. History of radiotherapy. History of chemotherapy. Smokers.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: PEEK Membrane Group
Participants undergo maxillary alveolar ridge augmentation using a customized perforated polyether ether ketone (PEEK) membrane in combination with particulate bone graft material prior to implant placement.
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Customized perforated polyether ether ketone (PEEK) membrane designed from preoperative CBCT data and used for guided bone regeneration during maxillary alveolar ridge augmentation.
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Eksperimentell: PTFE Membrane Group
Participants undergo maxillary alveolar ridge augmentation using a polytetrafluoroethylene (PTFE) membrane in combination with particulate bone graft material prior to implant placement.
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Polytetrafluoroethylene (PTFE) membrane used for guided bone regeneration during maxillary alveolar ridge augmentation.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Volumetric Bone Gain
Tidsramme: 6 months after surgery
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Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans. Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans. |
6 months after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
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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
Andre studie-ID-numre
- MS.26.01.108
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