RecruitingPhase 4NCT07384403

Application of Topical Oxygen Therapy Around Customized Healing Collar

Evaluation of Linear and Volumetric Soft Tissue Changes Following the Application of Topical Oxygen Therapy Around Customized Healing Collars: Case Series


Sponsor

Cairo University

Enrollment

6 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria6

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

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Interventions

PROCEDUREtopical oxygen therapy

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.


Locations(1)

Cairo university

Cairo, Egypt

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NCT07384403


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