Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation (sinus)
Clinical, Radiographic and Histologic Assessment of a New Xenograft Enhanced With Hydrogel in Augmentation of the Maxillary Sinus: A Randomized Controlled Trial
Implant supported dental restorations are sometimes challenging with decreased bone height in the posterior maxilla. The goal of this study is to test an augmentation bone substitute in elevating the maxillary sinus floor; in terms of soft tissue reaction, formed bone height as well as structure.
Bone substitute will be compared to a graftless method of bone augmentation depending on participants' bodies forming bone in the defective area.
Participants will:
- Undergo lateral maxillary sinus floor elevation with bone substitute or graftless method.
- Record postoperative swelling and pain through the follow up period.
- Take radiographs for evaluation of the formed bone before placing dental implants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Severe atrophy of the posterior maxilla is challenging when implant supported restorations are needed. This occurs with advanced bone loss following long standing extractions along with maxillary sinus pneumatisation leading to inadequate bone height to receive a dental implant. A variety of approaches of whether to use short implants, augment the defective site along with placing an implant or even a staged approach where the atrophic site is augmented as a primary stage followed by implant placement as a secondary stage -in cases of severe atrophy- are suggested. Different techniques, as well as materials, have been proposed for augmentation of the atrophic bone to receive an endosseous implant. To date, they are both subject to continuous modifications.
Aim is to assess a novel hydrogel-enhanced xenograft material; clinically, radiographically and histologically in lateral window maxillary sinus floor elevation in a staged augmentation approach. Null hypothesis suggests that there is no significant difference between using hydrogel-enhanced xenograft material in comparison with graftless augmentation of the maxillary sinus floor in terms of tissue reaction, formed bone quantity and quality. Whereas, the alternative hypothesis claims favourability of the hydrogel-enhanced xenograft over graftless augmentation of the maxillary sinus floor.
Thirty posterior maxillary edentulous sites requiring open sinus augmentation for staged dental implant placement will be studied. Patients will be randomly allocated into two groups. Group 1 (study group) will receive a xenograft enhanced with hydrogel after Shneiderian membrane elevation. Group 2 (control group) will have stainless steel screws/pins placed buccopalatally to maintain the elevated membrane and stabilize the formed blood clot as graftless augmentation. Surgeries will be evaluated clinically in terms of pain, edema and tissue response during the follow up period. Radiographic assessment will be performed during the surgical follow-up period and after 8 months; to evaluate the formed bone height and density using CBCT. After 8 months a cylindrical bone core using a trephine bur will be taken from the augmented site, this osteotomy will be further prepared to receive the implant. Bone cores from both groups will be examined histologically.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ramy H El Shater, MDS
- Numéro de téléphone: +201014111431
- E-mail: ramy.hamdy@miuegypt.edu.eg
Lieux d'étude
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Ismailia, Egypte
- Recrutement
- Suez Canal University
-
Contact:
- Mohamed El Sholqamy, Professor
- Numéro de téléphone: 00201014111431
- E-mail: ramy.hamdy@miuegypt.edu.eg
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Contact:
- Ramy El Shater, Assistant Lecturer
- Numéro de téléphone: 00201014111431
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egypte, 41522
- Recrutement
- Suez Canal University
-
Contact:
- El Sholqamy, Professor
- Numéro de téléphone: +20643205208
- E-mail: president_office@suez.edu.eg
-
Contact:
- Ramy, Assistant Lecturer
- Numéro de téléphone: +201014111431
- E-mail: ramy.hamdy@miuegypt.edu.eg
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adult male/female patients above the age of 18.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic posterior maxilla.
- Alveolar bone height less than 5 mm at the defective site.
- Good oral hygiene.
- Patient's consensual agreement to be enrolled in the study.
Exclusion Criteria:
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollement.
(Patients developing any medical condition that interferes with the outcomes after enrolment in the study will be excluded).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: control group
maxillary sinus membrane is elevated through a lateral window and held in place with screws buccopalatally, similar to tenting.
|
graftless augmentation of the maxillary sinus floor through membrane elevation and stabilization; tenting.
Autres noms:
|
|
Expérimental: study group
enhanced xenograft will be used to augment the maxillary sinus floor
|
hydrogel-enhanced xenograft
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
bone height gain
Délai: 8 months
|
radiographically, through CBCT
|
8 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
patient centered edema measurement
Délai: 0-7 days
|
linear measurements between specific reference points on the face
|
0-7 days
|
|
patient reported/related edema estimate
Délai: 3-7 days
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patients' assessment of swelling according to visual scale for edema
|
3-7 days
|
|
VAS pain
Délai: 10 days
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patients' assessment of pain 0-10 daily
|
10 days
|
|
bone structure
Délai: 8 months
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histological examination of harvested bone under microscope
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8 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- maxillary sinus pneumatization.
- severe posterior maxillary ridge atrophy.
- inadequate residual bone height.
- open sinus augmentation.
- lateral maxillary sinus floor elevation.
- tenting of the Schneiderian membrane.
- staged maxillary sinus floor augmentation and implant placement.
- modified xenografts.
- graftless augmentation.
- bone augmentation.
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/ 939
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
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produit fabriqué et exporté des États-Unis.
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