- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07586228
Guided Modified Socket Shield With Hyaluronic Acid for Black Triangle Management
Hyaluronic Acid With AI-Guided Immediate Implant Placement Using a Modified Socket Shield for Black Triangle Management: A Randomized Controlled Clinical Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: walid elamrousy, Phd
- Telefonnummer: 01029552024
- E-Mail: waled_hammed@den.kfs.edu.eg
Studieren Sie die Kontaktsicherung
- Name: Ahmed Abdelmoneim, bachelor
- Telefonnummer: 01061283932
- E-Mail: pg_1821970@dent.tanta.edu.eg
Studienorte
-
-
Kafrelsheikh
-
Kafr ash Shaykh, Kafrelsheikh, Ägypten, 214312
- faculty of dentistry, kafrelsheikh University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Flapless Socket shield technique with AI-based immediate implant placement
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
|
Computer guided socket shield with immediate implant placement
|
|
Experimental: Flapless Socket shield technique with AI-based immediate implant placement & Hyaluronic Acid
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
|
Computer guided socket shield with immediate implant placement with papilla injection by 0.2 mL of hyaluronic acid
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Interproximal papilla fill
Zeitfenster: 12-months
|
Using digital photographs the fill of interdental papilla will be assessed
|
12-months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
pink esthetic score
Zeitfenster: 12-months
|
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
|
12-months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Ahmed abdelmonem, bachelor, Faculty of Dentistry, Tanta University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OMPDR4-26/3575
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Zahnimplantat fehlgeschlagen
-
University of BaghdadRekrutierung
-
Marmara UniversityAbgeschlossenÄsthetik, DentalTruthahn
-
[Redacted]Dentsply Sirona Inc.ZurückgehaltenKlebstoff DentalVereinigtes Königreich
-
Thorsten GruenheidAbgeschlossen
-
Tanzila RafiqueAnmeldung auf EinladungDental Bonding | Dental Etching | Acid Etching | Acid Etching, Dental | Dental Acid EtchingBangladesch
-
University of Nove de JulhoAbgeschlossen
-
Kıvanç AkçaHacettepe UniversityAbgeschlossen
-
Hôpital RothschildAbgeschlossenÄsthetik, Dental
-
[Redacted]ZurückgehaltenKlebstoff DentalVereinigtes Königreich