- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07574606
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
Background and Rationale The rehabilitation of the severely atrophied maxilla utilizing zygomatic implants is a highly predictable and effective treatment modality. However, managing the peri-implant soft tissue in these complex cases remains a significant clinical challenge. Because zygomatic implants frequently emerge through thin, non-keratinized, and mobile alveolar mucosa rather than thick, attached gingiva, the peri-implant environment is highly susceptible to complications. Inadequate soft tissue thickness can lead to mucosal recession, exposure of the implant collar, plaque accumulation, and ultimately peri-implantitis, which threatens the long-term success of the prosthesis.
To mitigate these risks and achieve an optimal permucosal seal, soft tissue augmentation is often required. Vascularized soft tissue grafts are preferred in these compromised anatomical sites due to their robust blood supply and enhanced healing capacity. The Buccal Fat Pad (BFP) flap is a well-documented and frequently utilized technique for this purpose; however, its volume can be unpredictable, and it may be unavailable due to prior surgeries or anatomical deficiencies. Therefore, evaluating robust alternatives, such as the Palatal Pedicle Flap (PPF)-which utilizes the thick, keratinized palatal mucosa-is critical for optimizing surgical outcomes.
Study Design and Methodology This study is structured as a prospective, randomized controlled clinical trial utilizing a split-mouth design. The split-mouth approach is strategically chosen to eliminate inter-subject biological and immunological variability, allowing each patient to effectively serve as their own control. Patients presenting with a severely resorbed maxilla requiring bilateral zygomatic implant placement will be enrolled.
Following successful implant placement, the right and left maxillary quadrants will be randomized. One side will be assigned to receive soft tissue augmentation using the standard Buccal Fat Pad (BFP) flap, while the contralateral side will be assigned to receive the Palatal Pedicle Flap (PPF).
Surgical Intervention Overview All surgical procedures will be performed under appropriate anesthesia following standard sterile protocols.
For the BFP side: The buccal fat pad will be accessed via a vestibular mucosal incision, carefully bluntly dissected, mobilized, and advanced over the zygomatic implant collar without tension.
For the PPF side: A palatal pedicle flap will be meticulously outlined, elevated with its vascular supply intact, rotated, and adapted around the contralateral implant collar.
Both flaps will be secured using appropriate resorbable sutures to ensure tension-free primary closure and optimal tissue adaptation around the implant abutment interface. Post-operative care will adhere to standard institutional guidelines, including the prescription of appropriate analgesics, antibiotics, and antimicrobial mouth rinses.
Clinical Significance By systematically comparing the healing trajectories, tissue stability, and functional outcomes of the BFP and PPF techniques over a 6-month period, this trial aims to provide definitive, evidence-based guidance for soft tissue management in zygomatic implantology. Furthermore, it seeks to validate the PPF as a reliable and predictable reconstructive alternative in clinical scenarios where the buccal fat pad is deemed insufficient or inaccessible.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an
- Numéro de téléphone: 002 +20 10 06614712
- E-mail: waleed.fathy@fue.edu.eg
Sauvegarde des contacts de l'étude
- Nom: aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
- Numéro de téléphone: 002 00201000252400
- E-mail: Aya.magdy@fue.edu.eg
Lieux d'étude
-
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New Cairo
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Cairo, New Cairo, Egypte, 11835
- Recrutement
- Future University in Egypt
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Contact:
- lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor
- Numéro de téléphone: 00201099925769
- E-mail: laziz@fue.edu.eg
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Chercheur principal:
- mohamed abdelhamid maarouf eid, bachelor
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Patients ≥18 years with severely atrophic maxilla.
- Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
- Indicated for zygomatic implant-supported fixed prosthesis.
- Sufficient mouth opening for zygomatic implants placement.
- Patients willing to sign informed consent and attend follow-ups.
Exclusion Criteria:
- Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
- Heavy smokers
- Previous radiotherapy or bisphosphonate therapy.
- Active sinus or nasal infection.
- Severe parafunctional habits (e.g., bruxism).
- Pregnant or lactating women.
- Patients with psychiatric disorders affecting compliance.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Palatal pedicle flap coverage over zygomatic implant
a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone.
From the palatal side
|
a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone.
From the palatal side
|
|
Comparateur actif: Buccal fat pad coverage over zygomatic implant from the buccal side
|
covering the exposed part of the zygomatic implant using buccal fat pad from the buccal side.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Soft tissue thickness over the implant collar measured using a periodontal probe at 3 points on the buccal, surface mesial and distal to the implant platform.
Délai: 6 months
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ahmed abozekry, associate professor, oral and maxillofacial surgery at FUE
- Chercheur principal: omar magdy el awady, bachelor
- Chaise d'étude: Ramy Ragab El beialy, Professor, Cairo university in egypt oral and maxillofacial department
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FUE.REC(87)/11-2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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