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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.
Interventions
Preoperative Measures Prior to the second-stage surgical procedure, all participants will undergo a standardized preoperative assessment to ensure their suitability for implant exposure and subsequent healing abutment placement.
The following components will be systematically conducted:
Surgical Protocol
During the second-stage procedure, local anesthesia will be administered via infiltration using 2% lidocaine with 1:100,000 epinephrine. A mid-crestal or slightly palatal crestal incision will then be made to access the implant site.
Once osseointegration is clinically confirmed, the cover screw will be removed. Subsequently, a customized healing abutment(PEEK), appropriate to the implant diameter, will be placed and securely hand-tightened.
Application of Blue®M Gel:
Immediately following the placement of the healing abutment, Blue®M oral gel (Blue®M Europe BV, theNetherlands) will be applied circumferentially around the healing collar using a sterile microbrush. The gel will be gently massaged into the peri-implant mucosa and left in situ.
Postoperative instructions will include:
Postoperative Instructions and Follow-Up Patients will receive standard postoperative instructions and will be prescribed 0.12% chlorhexidine mouthwash to be used twice daily for one week. Analgesics (e.g., ibuprofen 400 mg) will be administered as needed. If sutures are used, they will be removed after 7-10 days.
Patients will be clinically evaluated at baseline (day of second-stage surgery), day 7, and day 21 for the following:
Horizontal and linear Soft tissue change ,Patient-reported outcomes (pain, discomfort),Digital photographs .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | assesse using the Numerical Rating Scale (NRS), where patients rated their pain intensity from 0 (no pain) to 10 (worst imaginable pain), either verbally or through a visual analog form. | baseline: at day 1 , day 3 , day 10 |
| Wound Healing |
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Inclusion Criteria:
Adults aged 21 years and above.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mulhem ahmed, bachelor | Contact | 00201050202633 | mulhem.ahmad@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mulhem ahmed | Cairo University | Principal Investigator |
| maie ismael | Cairo University | Study Chair |
| Mona Darhous |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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evaluated using the Modified Healing Index (MHI) as proposed by clinically scoring tissue color, swelling, exudate, necrosis, granulation, and epithelialization, with each parameter assigned a value and summed to reflect overall healing quality. |
| Baseline : day 1 , day 3 ,day 10 |
| Cairo University |
| Study Director |