Actively Recruiting
Evaluation of Soft Tissue Changes After Topical Oxygen Therapy Around Customized Healing Collars in Dental Implants
Led by Cairo University · Updated on 2026-02-03
6
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial focuses on improving soft tissue healing around dental implants, which is crucial for long-term success and aesthetics. Researchers are studying the use of topical oxygen therapy applied around customized healing abutments to better understand its effect on tissue regeneration, including linear and volumetric changes. This phase 4 study aims to provide clinical evidence to guide dental professionals in enhancing implant soft tissue management. Participants will undergo a thorough preoperative assessment including medical history, clinical and radiographic evaluations, and oral hygiene instruction before second-stage implant surgery. During surgery, a customized PEEK healing abutment is placed on the implant. Blue®M oral gel, which delivers topical oxygen, is applied around the healing collar immediately after placement and continued twice daily for 7 days. Standard postoperative care including chlorhexidine mouthwash and pain management is provided. Participants will be monitored with clinical evaluations at baseline, day 7, and day 21 to assess soft tissue changes, pain, wound healing, and clinical photographs. The main outcomes measured are soft tissue dimensional changes and the Pink Esthetic Score at baseline, 3 months, and 6 months post-treatment. Secondary outcomes include postoperative pain and wound healing assessments at days 1, 3, and 10. The total participation period covers these follow-ups to evaluate the therapy's impact.
CONDITIONS
Brief Title
Application of Topical Oxygen Therapy Around Customized Healing Collar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years and above
- Indicated for customized healing collar placement after second-stage implant surgery
- Good general health
- Able and willing to provide written informed consent
- Committed to follow-up visits
You will not qualify if you...
- Individuals younger than 21 years
- Systemic diseases affecting wound healing
- Smokers or tobacco users
- Pregnant or lactating women
- Using medications that affect soft tissue healing
- Receiving chemotherapy or radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo a standardized preoperative assessment followed by the second-stage implant surgery where a customized healing abutment is placed. Topical oxygen therapy with Blue®M oral gel is applied immediately around the healing collar and continued twice daily for 7 days.
1 baseline visit (second-stage surgery) plus daily self-application of gel for 7 days
Duration - 3 weeks
Participants are clinically evaluated to assess soft tissue changes, patient-reported pain and discomfort, and wound healing through visits at 7 and 21 days after surgery.
2 visits (at day 7 and day 21, in-person)
Trial Site Locations
Total: 1 location
1
Cairo university
Cairo, Egypt
Actively Recruiting
Research Team
M
Mulhem ahmed, bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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