Soft TissuePhase 4NCT07384403
Application of Topical Oxygen Therapy Around Customized Healing Collar
A Phase 4 study testing topical oxygen therapy in people with Soft Tissue and Healing Abutment Influence on Gingival Volume, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Soft Tissue, Healing Abutment Influence on Gingival Volume, Soft Tissue Healing
- What is being tested?
- topical oxygen therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals below 21 years old.
- Systemic diseases affecting healing.
- Smokers/tobacco users.
- Pregnant/lactating women.
- Medications affecting soft tissue healing.
- Chemotherapy/radiotherapy patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Linear and Volumetric Soft Tissue Changes Following the Application of Topical Oxygen Therapy Around Customized Healing Collars: Case Series
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.
Read the detailed description
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:
- Medical and Dental History Evaluation A comprehensive evaluation of each patient's medical and dental history will be performed to identify any systemic conditions or pharmacological agents that may compromise wound healing or elevate the risk of postoperative complications.
- Clinical and Radiographic Assessment A detailed clinical examination will be undertaken to evaluate the thickness of the soft tissue, the width of keratinized mucosa, and the condition of the mucosa overlying the implant site. Radiographic assessment using periapical radiographs or cone-beam computed tomography (CBCT), where indicated, will be conducted to confirm successful osseointegration of the dental implant and to exclude any evidence of peri-implant pathology.
- Oral Hygiene Evaluation and Instruction Oral hygiene status will be assessed using the Plaque Index. Patients will receive personalized oral hygiene instructions to ensure optimal plaque control before the surgical intervention. In cases where oral hygiene is deemed suboptimal, professional mechanical plaque removal (PMPR) will be provided, followed by re-evaluation prior to proceeding with the second-stage surgery.
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:
- Patients will be advised to refrain from rinsing or brushing the treated area for the first 12 hours.
- Blue®M gel application will be continued by the patient twice daily for 7 days postoperatively, in conjunction with standard oral hygiene measures.
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 .
- Conditions
- Soft Tissue, Healing Abutment Influence on Gingival Volume, Soft Tissue Healing, Dental Implant Healing
- Being tested
- topical oxygen therapy
- Keywords
- Oxygen gel, volumetic change of soft tissue, implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical oxygen therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: topical oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline: preoperative and after 3 months and after 6 months
Secondary outcomes (2)
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.
Measured: baseline: at day 1 , day 3 , day 10
Wound Healing
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.
Measured: Baseline : day 1 , day 3 ,day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft TissueStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mulhem Ahmad, Cairo University
- Investigators
- Mulhem ahmed, Principal investigator, Cairo Universitymaie ismael, Study chair, Cairo UniversityMona Darhous, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384403
- Sponsor's protocol ID
- per3312026
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Linear and Volumetric Soft Tissue Changes Following the Application of Topical Oxygen Therapy Around Customized Healing Collars: Case Series
- ClinicalTrials.gov ID
- NCT07384403
- Acronym / sponsor ID
- per3312026
- Conditions
- Soft Tissue, Healing Abutment Influence on Gingival Volume, Soft Tissue Healing, Dental Implant Healing
- Keywords
- Oxygen gel, volumetic change of soft tissue, implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Medical and Dental History Evaluation A comprehensive evaluation of each patient's medical and dental history will be performed to identify any systemic conditions or pharmacological agents that may compromise wound healing or elevate the risk of postoperative complications.
- Clinical and Radiographic Assessment A detailed clinical examination will be undertaken to evaluate the thickness of the soft tissue, the width of keratinized mucosa, and the condition of the mucosa overlying the implant site. Radiographic assessment using periapical radiographs or cone-beam computed tomography (CBCT), where indicated, will be conducted to confirm successful osseointegration of the dental implant and to exclude any evidence of peri-implant pathology.
- Oral Hygiene Evaluation and Instruction Oral hygiene status will be assessed using the Plaque Index. Patients will receive personalized oral hygiene instructions to ensure optimal plaque control before the surgical intervention. In cases where oral hygiene is deemed suboptimal, professional mechanical plaque removal (PMPR) will be provided, followed by re-evaluation prior to proceeding with the second-stage surgery.
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:
- Patients will be advised to refrain from rinsing or brushing the treated area for the first 12 hours.
- Blue®M gel application will be continued by the patient twice daily for 7 days postoperatively, in conjunction with standard oral hygiene measures.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical Oxygen therapy | Experimental | Procedure: topical oxygen therapyParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 21 years and above.
Key exclusion criteria (6 listed)
- Individuals below 21 years old.
- Systemic diseases affecting healing.
- Smokers/tobacco users.
- Pregnant/lactating women.
- Medications affecting soft tissue healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical oxygen therapyParticipants 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 or surgery | Topical Oxygen therapy |
Primary outcome
Soft tissue dimensional changes
Time frame: baseline: preoperative and after 3 months and after 6 months
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.
Pink Esthetic Score (PES)
Time frame: baseline: preoperative and after 3 months and after 6 months
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.
2 secondary outcomes
Postoperative Pain
Time frame: baseline: at day 1 , day 3 , day 10
Wound Healing
Time frame: Baseline : day 1 , day 3 ,day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mulhem ahmed principal investigator
Cairo University
maie ismael study chair
Cairo University
Mona Darhous study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical oxygen therapy in people with Soft Tissue and Healing Abutment Influence on Gingival Volume, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mulhem ahmed, bachelor (00201050202633, mulhem.ahmad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue dimensional changes (time frame: baseline: preoperative and after 3 months and after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.