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

NCT07844928 | Not Yet Recruiting

• 1 other identifier: MS.26.02.143
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Implants; Immediate Dental Implant Loading; Implant Stability

Keywords

Blue®M Gel; Topical Oxygen Therapy; Hyaluronic Acid; Implant Stability Quotient; Osseointegration; CBCT Bone Level; Immediately Loaded Implants

Outcome Measures

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.

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

Secondary Outcomes (1)

• Marginal (crestal) bone level changes around the dental implants

  6 months

Study Arms (3)

Control Group

NO INTERVENTION

Patients will receive immediately loaded dental implants without any surface conditioning or immersion in adjunctive agents prior to placement in the posterior maxilla

Blue®M Gel Group

EXPERIMENTAL

Patients will receive immediately loaded dental implants immersed in topical oxygen therapy gel (Blue®M Gel) prior to placement in the posterior maxilla

Other: Blue®M Gel

Hyaluronic Acid Group

EXPERIMENTAL

Patients will receive immediately loaded dental implants immersed in hyaluronic acid gel prior to placement in the posterior maxilla.

Other: Hyaluronic Acid

Interventions

Blue®M Gel OTHER

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

Blue®M Gel Group

Hyaluronic Acid OTHER

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

Hyaluronic Acid Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with systemic or local diseases contraindicating implant surgery.
• Smokers.
• History of radiotherapy or chemotherapy.
• Pregnant.

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (4)

• 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.

  PMID: 38541173 BACKGROUND

• 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.

  PMID: 33634616 BACKGROUND

• Elsayed MD. Biomechanical factors that influence the bone-implant interface. Res Rep Oral Maxillofac Surg. 2019;3(1):1-14.

  BACKGROUND

• Warreth A, Ibieyou N, O'Leary RB, Cremonese M, Abdulrahim M. Dental implants: an overview. Dent Update. 2017;44(7):596-620.

  BACKGROUND

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Fahad A Alqahtani

  Faculty of Dentistry, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad A Alqahtani, BDS

CONTACT

+201558123728; fa.3wad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied in this study due to the nature of the surgical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Topical Oxygen Therapy (Blue®M Gel) Versus Hyaluronic Acid on the Stability of Immediately Loaded Dental Implants in the Posterior Maxilla

Model Details: Participants will be randomly assigned into three parallel groups receiving different implant surface treatments prior to immediate loading in the posterior maxilla.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 28, 2026
• Study Start: September 12, 2026
• Primary Completion (Estimated): February 12, 2027
• Study Completion (Estimated): March 12, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share