- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03218228
Immediate Implant Placement in Aggressive Periodontitis (implant)
Evaluation of the Health of Peri-implant Tissues Around Immediately Placed Dental Implants in Aggressive Periodontitis Patients Versus Periodontally Healthy Individuals in Maxillary Esthetic Zone
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Aggressive periodontitis is an enigmatic periodontal disease that characterized by massive and undeterminable periods of tissue destruction. It gets along well to young individuals with successive periods of disease activity. Aggressive bone destruction with limited plaque and calculus deposits usually detected. According to microbial theory, Aggregatibacter actinomycetemcomitans (A.a) and P. gingivalis (P. G) were claimed for such a disease. Patients of aggressive periodontitis have disturbed esthetic and masticatory function problems.
After wards, microbial theory was modified to enroll the genetic background that can be the cause behind the developed body resistance. Although the importance of the genetic treatment to improve the body response, it was totally dismissed during the routine periodontal work attributable to high cost effectiveness of the needed genetic analysis especially in developing countries.
Further researches tried to explain the cause behind the impaired body response. Impaired functions of the immune cells and the massive amounts of catabolic cytokines such as IL-1, IL-6, Il-17, TNF- α and prostaglan¬din E2 (PGE2) are usually released during the active periods of the disease. On the other hand, matrix-metalloproteinases are destructive enzymes that released in an uncontrollable manner. Host modulators were suggested to control the released of the destructive agents.
Immediate implant placement provides an efficient modality that shortens the dental management period. The aim behind immediate implant placement is the proper implant positioning to counteract the advanced bone resorption following extraction.
Periodontitis is considered an important risk factor for peri-implantitis. The pre-existing periodontitis must be treated prior to implant placement in order to avoid the bacterial accumulation in the periodontal lesions regardless the type of periodontitis. Local and systemic supportive therapy is strongly recommended in order to reduce the microbial colonies and post-operative bone loss.
Higher rate of implant failure (peri-implantitis) has been reported in immediately placed implants when compared with the delayed conventional technique. The failure rate markedly increased with the immediate placement of implants in patients with history of periodontitis especially the aggressive form.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Giza, Egypte
- Recrutement
- Octobar University of Modern Sciences and Arts
-
Contact:
- nermin yussif, TA
- Numéro de téléphone: 01118271929
- E-mail: dr_nermin_yusuf@yahoo.com
-
Contact:
- rasha attia, TA
- Numéro de téléphone: 01009032255
- E-mail: periorasha1@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
• Subjects aged above 18 years old.
- Patients should be free from any systemic disease.
- patients with good oral hygiene
- completely or partially edenthulus patients
Exclusion Criteria:
Current and former smokers.
- Pregnant females.
- Patients with systemic diseases that may interfere with periodontal condition
- Uncooperative patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: implants in healthy individuals
immediate placement of dental implants in individuals with healthy periodontium.
the device is dental implants, radiographs, william's periodontal probe
|
it targets immediate implant placement in patients suffering from aggressive periodontitis
Autres noms:
|
|
Expérimental: implants in periodontitis patients
immediate implantation in patients suffering from aggressive periodontitis. the device is the dental implants, radiographs, william's periodontal probe
|
it targets immediate implant placement in patients suffering from aggressive periodontitis
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
implant and peri-implant tissues health
Délai: 12 months following implant placement
|
it includes evaluation of the health of the placed implant in aggressive periodontitis patients and the surrounding alveolar bone and soft tissue.
in other wards it evaluate the survival rate of the dental implants placed in aggressive periodontitis patients.
the health condition of the placed implants are evaluated according to scale called health scale which include 5 categories in which probing depth, alveolar bone ressorption, mobility, pain and other items are measured).
|
12 months following implant placement
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
midfacial peri-implant mucosal level
Délai: 12 months following implant placement
|
evaluattion of the mucosal level at the midfacial site of the immediately placed dental implants
|
12 months following implant placement
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: mona darhous, Prof, Faculty of Oral and Dental Medicine Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- immediate implant
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur implants in periodontitis
-
The Hearing Cooperative Research CentreRoyal Victoria Eye and Ear Hospital; CochlearComplétéPerte d'auditionAustralie
-
HK inno.N CorporationInconnue
-
HK inno.N CorporationActif, ne recrute pasFibrillation auriculaire non valvulaire (NVAF)Corée, République de
-
HK inno.N CorporationPas encore de recrutementVolontaires en bonne santéCorée du Sud
-
HK inno.N CorporationPas encore de recrutementDermatite atopique légère à modérée
-
HK inno.N CorporationComplétéNutrition parentéraleCorée, République de
-
University of Sao PauloComplétéCataracte | AstigmatismeBrésil
-
HK inno.N CorporationPas encore de recrutementConstipation idiopathique chroniqueCorée, République de
-
University of ChicagoNational Institutes of Health (NIH); National Institute of General Medical...Recrutement
-
Mentor Worldwide, LLCRetiréAugmentation | Révision d'augmentation | Augmentation mammaire générale | Involution post-lactationnelle | AsymétrieÉtats-Unis