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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Fahad A Alqahtani, BDS
- Telefoonnummer: +201558123728
- E-mail: fa.3wad@hotmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: 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 |
|
|
Experimenteel: 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. |
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Implant Stability Quotient (ISQ)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Marginal (crestal) bone level changes around the dental implants
Tijdsspanne: 6 months
|
assessed radiographically using standardized periapical radiographs during the 6-month follow-up period. |
6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Fahad A Alqahtani, Faculty of Dentistry, Mansoura University
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MS.26.02.143
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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