Application of Topical Oxygen Therapy Around Customized Healing Collar

NCT07384403 | Recruiting Phase 4

• 1 other identifier: per3312026
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The preservation and enhancement of peri-implant soft tissues are essential for the long-term success and esthetic integration of dental implants. Customized healing abutments have been introduced to support individualized soft tissue shaping; however, optimizing soft tissue healing around implants remains a clinical challenge. Oxygen plays a critical role in wound healing by promoting angiogenesis, fibroblast proliferation, and collagen synthesis. Topical oxygen therapy has shown promise in accelerating tissue regeneration, yet its application in oral implantology, particularly in conjunction with customized healing abutments, has not been adequately studied. This study aims to provide clinical evidence regarding the effectiveness of topical oxygen therapy in improving linear and volumetric soft tissue changes around dental implants. The findings may guide clinicians in refining soft tissue management protocols and contribute to establishing evidence-based practices in implant dentistry.

Conditions

Soft Tissue; Healing Abutment Influence on Gingival Volume; Soft Tissue Healing; Dental Implant Healing

Keywords

Oxygen gel; volumetic change of soft tissue; implant

Outcome Measures

Primary Outcomes (2)

• Soft tissue dimensional changes

  Horizontal Tissue Linear Alterations were measured in millimeters by superimposing baseline and follow-up 3D digital models and calculating the Mean Buccal Change (MBC) and Mean Total Change (MTC) using software such as ImageJ, Geomagic, or MeshLab at standardized buccal reference points. Vertical Linear Tissue Alterations were quantified in millimeters by evaluating changes in Mesial Papillae Height Variation (mPHv), Distal Papillae Height Variation (dPHv), Papillae Height Variation (PHv), and Midfacial Height Variation (MFHv) through calibrated digital photography or intraoral scanning relative to fixed anatomical landmarks.

  baseline: preoperative and after 3 months and after 6 months

• Pink Esthetic Score (PES)

  determined by scoring seven soft tissue parameters (papillae, mucosal contour, level, color, and texture) from 0 to 2, based on clinical photographs compared with adjacent teeth, yielding a total score ranging from 0 to 14.

  baseline: preoperative and after 3 months and after 6 months

Secondary Outcomes (2)

• Postoperative Pain

  baseline: at day 1 , day 3 , day 10

• Wound Healing

  Baseline : day 1 , day 3 ,day 10

Study Arms (1)

Topical Oxygen therapy

EXPERIMENTAL

Participants will undergo a standardized preoperative assessment prior to second-stage implant surgery, including medical and dental history review, clinical and radiographic evaluation to confirm implant osseointegration, and oral hygiene assessment with reinforcement as needed. During the second-stage procedure, local anesthesia will be administered, followed by a crestal incision to access the implant site. After removal of the cover screw, a customized PEEK healing abutment will be placed. Immediately after abutment placement, Blue®M oral gel (Blue®M Europe BV, The Netherlands) will be applied around the healing collar and gently massaged into the peri-implant mucosa. Participants will continue topical application twice daily for 7 days. Standard postoperative care will be provided. Clinical evaluations will be performed at baseline, 7 days, and 21 days to assess soft tissue changes, patient-reported outcomes, and clinical photographs.

Procedure: topical oxygen therapy

Interventions

topical oxygen therapy PROCEDURE

Participants will undergo a standardized preoperative assessment prior to second-stage implant surgery, including medical and dental history review, clinical and radiographic evaluation to confirm implant osseointegration, and oral hygiene assessment with reinforcement as needed. During the second-stage procedure, local anesthesia will be administered, followed by a crestal incision to access the implant site. After removal of the cover screw, a customized PEEK healing abutment will be placed. Immediately after abutment placement, Blue®M oral gel (Blue®M Europe BV, The Netherlands) will be applied around the healing collar and gently massaged into the peri-implant mucosa. Participants will continue topical application twice daily for 7 days. Standard postoperative care will be provided. Clinical evaluations will be performed at baseline, 7 days, and 21 days to assess soft tissue changes, patient-reported outcomes, and clinical photographs.

Topical Oxygen therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 21 years and above.
• Indicated for customized healing collar placement after second-stage surgery.
• Good general health.
• Able and willing to provide written informed consent.
• Committed to follow-up visits.

You may not qualify if:

• Individuals below 21 years old.
• Systemic diseases affecting healing.
• Smokers/tobacco users.
• Pregnant/lactating women.
• Medications affecting soft tissue healing.
• Chemotherapy/radiotherapy patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Mulhem ahmed

  Cairo University

  PRINCIPAL INVESTIGATOR

• maie ismael

  Cairo University

  STUDY CHAIR

• Mona Darhous

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mulhem ahmed, bachelor

CONTACT

00201050202633; mulhem.ahmad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Mulhem Ahmad

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 3, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

EG (1)