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Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone

11 september 2026 uppdaterad av: Xi Ding, First Affiliated Hospital of Wenzhou Medical University
This study plans to enroll no fewer than 48 adult patients who have non-restorable maxillary anterior teeth due to trauma or dental diseases and are candidates for immediate implant placement, meeting the inclusion and exclusion criteria.

Studieöversikt

Detaljerad beskrivning

This is a prospective, multicenter, parallel-group, evaluator-blinded randomized controlled trial.It aims to compare the Socket Shield Technique (SST) with conventional immediate implant placement (IIP) in the maxillary anterior aesthetic zone, evaluating labial bone plate thickness, implant survival/success rates, pink aesthetics, and patient satisfaction to assess their clinical efficacy and aesthetic outcomes.

Eligible participants will provide informed consent and be randomly assigned to groups via center-stratified randomization.

Primary endpoint: Changes in buccal bone plate thickness at the implant shoulder and at 2, 4, and 6 mm apically at 6 months after prosthetic restoration (T3).

Secondary endpoints: Implant survival and success rates; changes in buccal bone volume; changes in soft tissue contour convexity; Pink Esthetic Score (PES); patient satisfaction; operative time, pain levels, and treatment-related parameters.

Safety endpoints: Intraoperative and postoperative adverse events, including infection, bleeding, wound dehiscence, implant loosening, peri-implantitis, shield fragment displacement/exposure/dislodgement, need for reoperation, and other serious adverse events (SAEs).

Studietyp

Interventionell

Inskrivning (Beräknad)

48

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age: 18 to 65 years old;

    • Good general health, able to tolerate oral implant surgery, with no absolute surgical contraindications (ASA I or II);

      • Clinical diagnosis of an unrestorable maxillary anterior tooth, suitable for immediate implant placement; ④ Periodontal tissues are basically healthy, with no obvious active infection in the apical area; ⑤ No obvious root fracture on the labial/buccal side or severe mobility preoperatively; radiographic evaluation confirms that the bone volume in the surgical site meets the requirements of the protocol; ⑥ Willing to accept randomization and standardized follow-up, and has signed the Informed Consent Form; ⑦ Able to provide complete intraoral photographs, CBCT (Cone Beam Computed Tomography) scans, and follow-up data.

Exclusion Criteria:

  • Presence of severe systemic diseases that may affect the surgery or healing, or current use of related medications such as bisphosphonates;

    • Severe periodontal disease or uncontrolled poor oral hygiene;

      • Obvious inflammation in the apical area of the affected tooth, or pathological root resorption; ④ Abnormal occlusal relationship, obvious bruxism, or inability to establish a stable restorative occlusion;

        • Pregnancy or lactation, or unsuitability for radiographic examination; ⑥ History of previous surgery or radiotherapy affecting the bone volume or soft tissues in the target area, which the investigator deems would seriously interfere with the evaluation; ⑦ Expected inability to complete the follow-up, or refusal to comply with the study requirements.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: the Socket Shield Technique (SST)
the Socket Shield Technique (SST) immediate implant placement

During tooth extraction, a stable buccal root fragment (shield) is preserved. The specific procedures are as follows:

Minimally invasively extract the crown of the affected tooth, preserving a buccal root fragment approximately 1-2 mm in thickness; Adjust the coronal aspect of the root fragment to approximately 2 mm apical to the gingival margin, ensuring a rounded and blunt coronal edge that is flush with the alveolar crest; Maintain the integrity of the buccal bone plate without any fractures;

Andra namn:
  • Group SST
Aktiv komparator: conventional immediate implant placement (IIP)

Completely remove the root of the affected tooth and complete the procedure according to the conventional immediate implant placement protocol:

Minimally invasively extract the affected tooth (complete root extraction); Place the implant within the extraction socket (biased toward the palatal side); Fill the jump gap with a low-resorption xenogeneic bone substitute material; Perform soft and hard tissue management according to the conventional immediate implant placement SOP.

Andra namn:
  • Group IIP

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Thickness of the labial bone plate
Tidsram: 6 months after the restoration (T3)
The changes in the thickness of the labial bone plate at the implant shoulder and 2, 4, and 6 mm below
6 months after the restoration (T3)

Sekundära resultatmått

Resultatmått
Tidsram
Implant retention and success rate
Tidsram: 3, 6,12 ,24 and 36 months after the operaiton
3, 6,12 ,24 and 36 months after the operaiton
Volume change of the labial bone plate
Tidsram: 6 months after the crown restoration was completed
6 months after the crown restoration was completed
Change in the contour curvature of soft tissues
Tidsram: 6 months after the crown restoration was completed
6 months after the crown restoration was completed
Pink Aesthetic Score (PES)
Tidsram: 6 months after the crown restoration was completed
6 months after the crown restoration was completed
Patients' satisfaction degree
Tidsram: On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed
On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 januari 2027

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

11 september 2026

Först inskickad som uppfyllde QC-kriterierna

11 september 2026

Första postat (Faktisk)

16 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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