Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement
Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area
Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.
Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients age between 20-45 years with no gender predilection.
- Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
- Patients with good oral hygiene.
- Bony defects more than 2 mm during implant placement treated by bone substitute.
- Patients fully capable to comply with the study protocol.
Exclusion Criteria:
- Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
- Heavy smokers (more than 20 cigarettes per day).
- Sites with acute oral infection.
- Pregnant and lactating patients.
- Untreated periodontal disease.
- Previous chemotherapy or irradiation of the head and neck.
- Inadequate interocclusal space.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention group
10 patients will have immediate implant placement with buccal pad of fat free tissue
|
Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Délai: 6 months
|
Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using: a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain). |
6 months
|
|
Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Délai: 6 months
|
Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
|
6 months
|
|
Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Délai: 6 months
|
Evaluation of soft tissue healing At week 1, week4 and at 6 months: Presence/absence of postoperative complications will be evaluated, including: Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation. |
6 months
|
|
Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
Délai: 6 months
|
Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
|
6 months
|
|
Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Délai: 6 months
|
After 3 months then at 6 months Cone Beam CT will be requested in order to measure:
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Lobna Elwan, BSc, Alexandria University
- Directeur d'études: Nagy El Prince, PhD, Alexandria University
- Directeur d'études: Ahmed O. Swedan, PhD, Alexandria University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- Buccal pad of fat free tissue
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
produit fabriqué et exporté des États-Unis.
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