About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with systemic or local diseases contraindicating implant surgery.
Smokers.
History of radiotherapy or chemotherapy.
Pregnant.
Trial design
Parallel
Treatments tested in this trial
Blue®M Gel
Other interventionTopical oxygen-releasing gel used for implant surface conditioning prior to placement to enhance healing and implant stability.
Hyaluronic Acid
Other interventionViscoelastic gel used for implant surface immersion prior to placement to enhance soft and hard tissue healing and improve implant stability.
Treatment groups
Trial outcomes
Primary outcomes
Implant Stability Quotient (ISQ)
Primary implant stability will be measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values.
Secondary outcomes
Marginal (crestal) bone level changes around the dental implants
assessed radiographically using standardized periapical radiographs during the 6-month follow-up period.
Locations
Sponsors and contacts
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