Blue®M Gel Versus Hyaluronic Acid for Stability of Immediately Loaded Dental Implants
Topical Oxygen Therapy (Blue®M Gel) Versus Hyaluronic Acid on the Stability of Immediately Loaded Dental Implants in the Posterior Maxilla
This randomized controlled clinical trial aims to compare the effect of topical oxygen therapy (Blue®M Gel) and hyaluronic acid on the stability of immediately loaded dental implants placed in the posterior maxilla. Twenty-four dental implants will be placed in eligible patients and randomly assigned to one of three groups: control implants without surface treatment, implants immersed in Blue®M Gel before placement, and implants immersed in hyaluronic acid gel before placement.
Implant stability will be evaluated using resonance frequency analysis immediately after implant placement and during follow-up. Clinical healing outcomes, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection, will also be assessed. Radiographic evaluation of crestal bone level changes will be performed using cone beam computed tomography (CBCT). The study seeks to determine whether topical oxygen therapy or hyaluronic acid can improve implant stability and peri-implant healing in the posterior maxilla.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Dental implants are a predictable treatment option for the replacement of missing teeth. However, implant placement in the posterior maxilla remains challenging because of reduced bone density, sinus pneumatization, and limited residual bone volume. Achieving adequate primary stability is particularly important when immediate loading protocols are used.
Blue®M Gel is an oxygen-releasing topical gel that provides controlled delivery of active oxygen and contains lactoferrin, which may support wound healing, reduce bacterial load, and enhance tissue regeneration. Hyaluronic acid is a naturally occurring glycosaminoglycan that plays an important role in tissue repair, modulation of inflammation, and bone regeneration. Both materials have demonstrated beneficial effects on soft and hard tissue healing.
This study will be conducted as a randomized controlled clinical trial including patients requiring replacement of one or more missing teeth in the posterior maxilla. A total of 24 implants will be inserted and randomly allocated into three equal groups:
Group I: Immediate loaded implants without surface treatment (control group).
Group II: Immediate loaded implants immersed in Blue®M Gel before placement.
Group III: Immediate loaded implants immersed in hyaluronic acid gel before placement.
All implants will be placed using a standardized surgical protocol. Implant stability will be measured immediately after placement and at follow-up intervals using resonance frequency analysis and Implant Stability Quotient (ISQ) values. Clinical healing parameters will be evaluated postoperatively, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection. Radiographic assessment of crestal bone level changes will be performed using CBCT imaging.
The primary objective of the study is to compare the effect of topical oxygen therapy and hyaluronic acid on implant stability in immediately loaded dental implants placed in the posterior maxilla. Secondary objectives include evaluation of peri-implant soft tissue healing and radiographic bone changes during the follow-up period.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fahad A Alqahtani, BDS
- Numéro de téléphone: +201558123728
- E-mail: fa.3wad@hotmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients aged 18-45 years.
- Patients with one or more missing teeth in the posterior maxilla.
- Adequate bone volume (width ≥ 6 mm and height ≥ 12 mm from maxillary sinus floor).
- Good oral hygiene and motivation for oral rehabilitation.
Exclusion Criteria:
- Patients with systemic or local diseases contraindicating implant surgery.
- Smokers.
- History of radiotherapy or chemotherapy.
- Pregnant.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Group
Patients will receive immediately loaded dental implants without any surface conditioning or immersion in adjunctive agents prior to placement in the posterior maxilla |
|
|
Expérimental: Blue®M Gel Group
Patients will receive immediately loaded dental implants immersed in topical oxygen therapy gel (Blue®M Gel) prior to placement in the posterior maxilla |
Topical oxygen-releasing gel used for implant surface conditioning prior to placement to enhance healing and implant stability. |
|
Expérimental: Hyaluronic Acid Group
Patients will receive immediately loaded dental implants immersed in hyaluronic acid gel prior to placement in the posterior maxilla. |
Viscoelastic gel used for implant surface immersion prior to placement to enhance soft and hard tissue healing and improve implant stability. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Implant Stability Quotient (ISQ)
Délai: Immediately after implant placement and follow up visits during the 6 months
|
Primary implant stability will be measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values. |
Immediately after implant placement and follow up visits during the 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Marginal (crestal) bone level changes around the dental implants
Délai: 6 months
|
assessed radiographically using standardized periapical radiographs during the 6-month follow-up period. |
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Fahad A Alqahtani, Faculty of Dentistry, Mansoura University
Publications et liens utiles
Publications générales
- Shaheen MY, Abas I, Basudan AM, Alghamdi HS. Local Oxygen-Based Therapy (blue(R)m) for Treatment of Peri-Implant Disease: Clinical Case Presentation and Review of Literature about Conventional Local Adjunct Therapies. Medicina (Kaunas). 2024 Mar 8;60(3):447. doi: 10.3390/medicina60030447.
- Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
- Elsayed MD. Biomechanical factors that influence the bone-implant interface. Res Rep Oral Maxillofac Surg. 2019;3(1):1-14.
- Warreth A, Ibieyou N, O'Leary RB, Cremonese M, Abdulrahim M. Dental implants: an overview. Dent Update. 2017;44(7):596-620.
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MS.26.02.143
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data (IPD) will not be shared due to ethical and confidentiality considerations. The dataset contains sensitive clinical and radiographic information related to dental implant patients, and sharing may compromise patient privacy. Additionally, no plan for external data sharing or public repository submission has been established for this study.
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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