Blue®M Gel Versus Hyaluronic Acid for Stability of Immediately Loaded Dental Implants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMansoura University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blue®M Gel

    Other intervention

    Topical oxygen-releasing gel used for implant surface conditioning prior to placement to enhance healing and implant stability.

  • Hyaluronic Acid

    Other intervention

    Viscoelastic gel used for implant surface immersion prior to placement to enhance soft and hard tissue healing and improve implant stability.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Blue®M Gel GroupExperimental treatment 1 intervention
Group C: Hyaluronic Acid GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implant Stability Quotient (ISQ)

Primary implant stability will be measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values.

Time frame
Immediately after implant placement and follow up visits during the 6 months

Secondary outcomes

1

Marginal (crestal) bone level changes around the dental implants

assessed radiographically using standardized periapical radiographs during the 6-month follow-up period.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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