Dental Implant FailedNCT07586228
Guided Modified Socket Shield With Hyaluronic Acid for Black Triangle Management
A study testing Guided socket shield without Hyaluronic acid and Guided socket shield with hyaluronic acid in people with Dental Implant Failed, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The Primary aim of this study will be to evaluate the clinical, esthetic, and radiographic outcomes of hyaluronic acid combined with immediate implant placement using AI-assisted and computer guided modified socket shield technique in maxillary anterior sites exhibiting black triangles. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Guided socket shield without Hyaluronic acid and Guided socket shield with hyaluronic acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2026to 15 Jun 2027
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults (20-50) years old.
- Single rooted maxillary anterior teeth with hopeless prognosis.
- Periodontally compromised but with >50% remaining bone.
- Presence of black triangle ≥2 mm.
- Systemically healthy.
Who cannot join
- Medically compromised patients and systemic conditions that complicate implant placement as uncontrolled diabetes, osteoporosis.
- Alcoholic and Smokers patients.
- Pregnant or lactating women.
- Acute Pathology or infection at implant site
- Patients with a history of chemotherapy, radiotherapy in head and/or neck region.
- Patients on bisphosphonate or steroids therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Hyaluronic Acid With AI-Guided Immediate Implant Placement Using a Modified Socket Shield for Black Triangle Management: A Randomized Controlled Clinical Trial
The Primary aim of this study will be to evaluate the clinical, esthetic, and radiographic outcomes of hyaluronic acid combined with immediate implant placement using AI-assisted and computer guided modified socket shield technique in maxillary anterior sites exhibiting black triangles.
Read the detailed description
The growing patient demand for quicker aesthetic solutions has led oral implantologists to adopt more immediate protocols compared to the delayed approach originally recommended by Brånemark. Studies have shown that implants placed immediately after atraumatic extraction can achieve success rates comparable to those placed in healed sockets. Other findings reported favorable results with immediate implant placement, including reduced resorptive bone changes post-extraction.
Following extraction, the alveolar ridge undergoes changes that often result in bone loss. This is mainly due to the elimination of periodontal ligament attachments and trauma during extraction, with the buccal bone plate being especially affected. Retaining part of the root has been shown to help preserve bone in pontic areas. In 2010, Hürzeler et al. introduced the socket shield technique to mitigate post-extraction bone loss by maintaining the labial portion of the root. Their results indicated stabilized buccal bone height.
Multiple modifications of the socket shield technique have since emerged. Modified socket shield technique (MSST), that involved thinning the labial shield to 1.5 mm, keeping it at the crest level, and leaving the space (jumping gap) between implant and shield without grafting . Some studies highlight the role of grafting this gap in achieving better outcomes. A histological investigation in sheep compared bone healing with and without grafting and found that although bone formed in both cases, the ungrafted bone was structurally weak and had fewer trabeculae, making it unsuitable for supporting masticatory loads.
Human histology showed that this gap could allow soft tissue ingrowth. Currently, there is no definitive human research proving the necessity of grafting in this context. Therefore, Gluckman emphasized the need for further clinical studies to evaluate the benefits of grafting the jumping gap in the MSST protocol.
Artificial intelligence (AI) has transformed digital planning and clinical execution in implant dentistry. AI-based tools analyze CBCT data, segment anatomical structures, identify vital landmarks, and simulate prosthetically driven implant positions with high accuracy. AI can improve implant positioning, angulation, depth control, and proximity to anatomical structures. It reduces surgical errors and improves long-term outcomes.
AI also enables precision in guide design and improves the predictability of immediate implant protocols. In esthetically demanding cases, such as those involving anterior maxillary implants, AI enhances decision-making and reduces clinician variability. It further allows prediction of soft and hard tissue changes through machine learning models trained on clinical imaging data.
In compromised situations, such as periodontally involved teeth, AI supports better planning by incorporating bone quality, defect morphology, and risk factors into surgical execution . It can detect critical patterns in bone loss, root anatomy, and soft tissue contours, guiding shield design and implant orientation.
Implant placement in sites previously affected by periodontitis poses risks. These sites often present with reduced bone volume, loss of papilla, apical migration of soft tissue, and compromised blood supply. Residual periodontal pathogens and altered healing responses make these areas less predictable for osseointegration.
Immediate implant placement in such sites requires careful evaluation. Inadequate primary stability and poor soft tissue support increase implant failure risk. Using guided protocols, with the support of AI and advanced techniques like root shielding, can help reduce complications. Maintaining remaining structures and optimizing healing are critical in these patients.
Reconstructing the interdental papilla remains one of the most demanding aesthetic challenges in periodontology. The interdental papilla contributes not only to appearance but also to function. It also plays a protective role for the periodontium by preventing debris accumulation. Black triangles may develop. These can result from aging, tooth shape, or periodontal conditions.
Over the years, several surgical strategies, such as coronally advanced flaps or subepithelial connective tissue grafts, have been proposed. These interventions often yield inconsistent outcomes due to limited blood flow and the small size of the papillary area. ] Recently, non-surgical techniques have gained attention for papilla reconstruction. These include prosthetic adjustments, restorative procedures, and orthodontic interventions. One minimally invasive option is the injection of hyaluronic acid gel (HA) to restore lost interdental papilla between teeth or implants. This approach is considered safe and shows promising outcomes. HA is a naturally found linear polysaccharide in the extracellular matrix and exists in gingival tissues and the periodontal ligament. Its clinical effect usually lasts between 6 and 12 months.
Due to its hygroscopic properties, HA contributes to lubrication, volume maintenance, protein exclusion, and shock absorption in papillary gaps. It also supports wound healing, tissue repair, and the structural balance of periodontal tissues.
As far as the authors are aware, this is the first study utilizing socket shield approach in periodontally compromised sites \& the first study that combines AI assisted and computer guided socket shield with HA in periodontally compromised sites in anterior esthetic zone.
- Conditions
- Dental Implant Failed
- Being tested
- Guided socket shield without Hyaluronic acid, Guided socket shield with hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided socket shield without Hyaluronic acidProcedure or surgery
Computer guided socket shield with immediate implant placement
Guided socket shield with hyaluronic acidProcedure or surgery
Computer guided socket shield with immediate implant placement with papilla injection by 0.2 mL of hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Flapless Socket shield technique with AI-based immediate implant placement | Experimental | The root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement Receives: Procedure: Guided socket shield without Hyaluronic acid |
| Flapless Socket shield technique with AI-based immediate implant placement & Hyaluronic Acid | Experimental | The root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement then 0.2 mL of hyaluronic acid was injected into the interproximal papillary area Receives: Procedure: Guided socket shield with hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interproximal papilla fill
Using digital photographs the fill of interdental papilla will be assessed
Measured: 12-months
Secondary outcomes (1)
pink esthetic score
The Pink Esthetic Score (range: 0-14) was assessed based on digital intraoral photographs by assigning a score of 0 to 2 for the following criteria compared to the adjacent reference tooth: mesial and distal papillae, soft tissue color, texture, level, contour, and alveolar bone defect
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel arm single blinding
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- Ahmed abdelmonem, bachelor, Study chair, Faculty of dentistry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586228
- Sponsor's protocol ID
- OMPDR4-26/3575
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid With AI-Guided Immediate Implant Placement Using a Modified Socket Shield for Black Triangle Management: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07586228
- Acronym / sponsor ID
- OMPDR4-26/3575
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 14 May 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 Primary aim of this study will be to evaluate the clinical, esthetic, and radiographic outcomes of hyaluronic acid combined with immediate implant placement using AI-assisted and computer guided modified socket shield technique in maxillary anterior sites exhibiting black triangles.
Detailed description
The growing patient demand for quicker aesthetic solutions has led oral implantologists to adopt more immediate protocols compared to the delayed approach originally recommended by Brånemark. Studies have shown that implants placed immediately after atraumatic extraction can achieve success rates comparable to those placed in healed sockets. Other findings reported favorable results with immediate implant placement, including reduced resorptive bone changes post-extraction.
Following extraction, the alveolar ridge undergoes changes that often result in bone loss. This is mainly due to the elimination of periodontal ligament attachments and trauma during extraction, with the buccal bone plate being especially affected. Retaining part of the root has been shown to help preserve bone in pontic areas. In 2010, Hürzeler et al. introduced the socket shield technique to mitigate post-extraction bone loss by maintaining the labial portion of the root. Their results indicated stabilized buccal bone height.
Multiple modifications of the socket shield technique have since emerged. Modified socket shield technique (MSST), that involved thinning the labial shield to 1.5 mm, keeping it at the crest level, and leaving the space (jumping gap) between implant and shield without grafting . Some studies highlight the role of grafting this gap in achieving better outcomes. A histological investigation in sheep compared bone healing with and without grafting and found that although bone formed in both cases, the ungrafted bone was structurally weak and had fewer trabeculae, making it unsuitable for supporting masticatory loads.
Human histology showed that this gap could allow soft tissue ingrowth. Currently, there is no definitive human research proving the necessity of grafting in this context. Therefore, Gluckman emphasized the need for further clinical studies to evaluate the benefits of grafting the jumping gap in the MSST protocol.
Artificial intelligence (AI) has transformed digital planning and clinical execution in implant dentistry. AI-based tools analyze CBCT data, segment anatomical structures, identify vital landmarks, and simulate prosthetically driven implant positions with high accuracy. AI can improve implant positioning, angulation, depth control, and proximity to anatomical structures. It reduces surgical errors and improves long-term outcomes.
AI also enables precision in guide design and improves the predictability of immediate implant protocols. In esthetically demanding cases, such as those involving anterior maxillary implants, AI enhances decision-making and reduces clinician variability. It further allows prediction of soft and hard tissue changes through machine learning models trained on clinical imaging data.
In compromised situations, such as periodontally involved teeth, AI supports better planning by incorporating bone quality, defect morphology, and risk factors into surgical execution . It can detect critical patterns in bone loss, root anatomy, and soft tissue contours, guiding shield design and implant orientation.
Implant placement in sites previously affected by periodontitis poses risks. These sites often present with reduced bone volume, loss of papilla, apical migration of soft tissue, and compromised blood supply. Residual periodontal pathogens and altered healing responses make these areas less predictable for osseointegration.
Immediate implant placement in such sites requires careful evaluation. Inadequate primary stability and poor soft tissue support increase implant failure risk. Using guided protocols, with the support of AI and advanced techniques like root shielding, can help reduce complications. Maintaining remaining structures and optimizing healing are critical in these patients.
Reconstructing the interdental papilla remains one of the most demanding aesthetic challenges in periodontology. The interdental papilla contributes not only to appearance but also to function. It also plays a protective role for the periodontium by preventing debris accumulation. Black triangles may develop. These can result from aging, tooth shape, or periodontal conditions.
Over the years, several surgical strategies, such as coronally advanced flaps or subepithelial connective tissue grafts, have been proposed. These interventions often yield inconsistent outcomes due to limited blood flow and the small size of the papillary area. ] Recently, non-surgical techniques have gained attention for papilla reconstruction. These include prosthetic adjustments, restorative procedures, and orthodontic interventions. One minimally invasive option is the injection of hyaluronic acid gel (HA) to restore lost interdental papilla between teeth or implants. This approach is considered safe and shows promising outcomes. HA is a naturally found linear polysaccharide in the extracellular matrix and exists in gingival tissues and the periodontal ligament. Its clinical effect usually lasts between 6 and 12 months.
Due to its hygroscopic properties, HA contributes to lubrication, volume maintenance, protein exclusion, and shock absorption in papillary gaps. It also supports wound healing, tissue repair, and the structural balance of periodontal tissues.
As far as the authors are aware, this is the first study utilizing socket shield approach in periodontally compromised sites \& the first study that combines AI assisted and computer guided socket shield with HA in periodontally compromised sites in anterior esthetic zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel arm single blinding
| Arm | Type | Receives |
|---|---|---|
| Flapless Socket shield technique with AI-based immediate implant placement | Experimental | Procedure: Guided socket shield without Hyaluronic acidThe root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement |
| Flapless Socket shield technique with AI-based immediate implant placement & Hyaluronic Acid | Experimental | Procedure: Guided socket shield with hyaluronic acidThe root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement then 0.2 mL of hyaluronic acid was injected into the interproximal papillary area |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults (20-50) years old.
- Single rooted maxillary anterior teeth with hopeless prognosis.
- Periodontally compromised but with >50% remaining bone.
- Presence of black triangle ≥2 mm.
- Systemically healthy.
Key exclusion criteria (6 listed)
- Medically compromised patients and systemic conditions that complicate implant placement as uncontrolled diabetes, osteoporosis.
- Alcoholic and Smokers patients.
- Pregnant or lactating women.
- Acute Pathology or infection at implant site
- Patients with a history of chemotherapy, radiotherapy in head and/or neck region.
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 |
|---|---|---|
| Guided socket shield without Hyaluronic acidComputer guided socket shield with immediate implant placement | Procedure or surgery | Flapless Socket shield technique with AI-based immediate implant placement |
| Guided socket shield with hyaluronic acidComputer guided socket shield with immediate implant placement with papilla injection by 0.2 mL of hyaluronic acid | Procedure or surgery | Flapless Socket shield technique with AI-based immediate implant placement & Hyaluronic Acid |
Primary outcome
Interproximal papilla fill
Time frame: 12-months
Using digital photographs the fill of interdental papilla will be assessed
1 secondary outcome
pink esthetic score
Time frame: 12-months
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 15 May 2026.
- Individual participant dataSharing planned: No
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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.
Ahmed abdelmonem, bachelor study chair
Faculty of dentistry, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided socket shield without Hyaluronic acid and Guided socket shield with hyaluronic acid in people with Dental Implant Failed, run by Kafrelsheikh 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: opening soon, as of the sponsor's last update on 15 May 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.
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 walid elamrousy, Phd (01029552024, waled_hammed@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interproximal papilla fill (time frame: 12-months). 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 15 May 2026.