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Valutazione dell'Efficacia della Tecnica di Inibizione Periostale Modificata (MPI), Durante il Posizionamento Immediato dell'Impianto, sulle Variazioni Dimensionali dell'Osso Alveolare, a Confronto con l'Approccio Convenzionale all'Impianto Immediato Senza Scollamento

7 novembre 2026 aggiornato da: Meran Farid Hamza Awad, Mansoura University

Impatto della Tecnica di Inibizione Periostale Modificata sulla Stabilità Ossea Alveolare nelle Procedure di Inserimento Immediato di Impianti (Studio Clinico Controllato Randomizzato)

To clinically and radiographically assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement, on alveolar bone dimensional changes, in comparison to the conventional flapless immediate implant approach.

Panoramica dello studio

Descrizione dettagliata

To assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement in comparison to the conventional flapless immediate implant approach on radiographically by assessing marginal bone level measurements and bucco-lingual alveolar width. Clinically, pain levels, wound healing index, primary, secondary implant stability measured by resonance frequency analysis (RFA), peri-implant probing depth, and pink esthetic score (PES) will be assessed.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Al Mansurah, Egitto
        • Faculty of Dentistry, Mansoura university

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patient's age ranges between 20 and 50 years including both genders.
  • General good health (American Society of Anesthesiologists I-II).
  • Presence of one hopeless non-restorable tooth requiring extraction at the posterior region.
  • Adequate amount of palatal bone and basal bone (≥ 3 mm) to engage the immediately placed implants.
  • Adequate keratinized soft tissue.
  • Thick gingival phenotype (˃ 1.5 mm).
  • Thin buccal bone plate or presence of fenestration.
  • Favorable pattern of occlusion.
  • Patient who is able to understand and sign a written consent.

Exclusion Criteria:

  • Pregnancy or lactating females.
  • Untreated periodontitis.
  • Acute dentoalveolar infection.
  • Complete absence of buccal bone plate.
  • Osteometabolic disease.
  • Chemotherapy or radiation therapy history of the neck-head area within the past 12 months.
  • Heavy smokers (>20 cigarettes/per day) according to WHO.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Flapless immediate implant placement with cortico-cancellous bone allograft in the gap distance

Participants receive immediately inserted implant via flapless approach with the grafting of cortico-cancellous bone allograft in the gap distance between dental implant and surrounding native alveolar bone followed by insertion of customized healing abutment.

Implant site preparation will be performed flapless using 3D computer assisted planned surgical stent. Implant site preparation will be performed using commercially available standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. Cortico-cancellous bone allograft will be inserted inside the extraction socket in the gap distance between the implant and surrounding alveolar bone of the fresh extraction socket.

Sperimentale: Immediate implant placement with MPI technique using collagen sponge in gap distance

Participants receive immediately inserted implant in conjunction with modified periosteal inhibition technique (MPI) after flap reflection from the buccal side and fixation of a 0.5 mm-thick cortical lamina glued to the buccal cortex with cyanoacrylate material. Collagen sponge will be filled in the gap distance followed by insertion of customized healing abutment.

After papillae incisions, an intra-sulcular incision will be made on the vestibular side of the extraction socket, extending to the mesial and distal mid-tooth with a #15c surgical scalpel. Implant site preparation will be performed using 3D computer assisted planned surgical stent. Implant site preparation will be performed using a standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. A full-thickness flap will be elevated creating a room that would allow the insertion of the cortical lamina. Cortical Lamina (0.5 mm thick) will be left in saline solution for 5 minutes and then cut to the desired shape, ranging from 8 to 10 mm in height, extending up to the mesial and distal margins of the extraction socket, molded until perfect fit and glued with two or three drops of N-butyl cyanoacrylate. A collagen sponge will be inserted inside the extraction socket to stabilize the clot. Suturing the papillae using 5-0 polypropylene monofilament.

Sperimentale: Immediate implant with MPI technique using cortico-cancellous bone allograft in gap distance

Participants receive immediately inserted implant in conjunction with MPI technique as described in group 2, however, cortico-cancellous bone allograft will be placed in the gap distance instead of collagen sponge and followed by insertion of customized healing abutment.

After papillae incisions, an intra-sulcular incision will be made on the vestibular side of the extraction socket, extending to the mesial and distal mid-tooth with a #15c surgical scalpel. Implant site preparation will be performed using 3D computer assisted planned surgical stent. Implant site preparation will be performed using a standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. A full-thickness flap will be elevated creating a room that would allow the insertion of the cortical lamina. Cortical Lamina (0.5 mm thick) will be left in saline solution for 5 minutes and then cut to the desired shape, ranging from 8 to 10 mm in height, extending up to the mesial and distal margins of the extraction socket, molded until perfect fit and glued with two or three drops of N-butyl cyanoacrylate. cortico-cancellous bone allograft will be inserted in the gap distance. Suturing the papillae using 5-0 polypropylene monofilament.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiographic evaluation of horizontal and vertical dimensional changes of the alveolar bone placement by using cone beam computed tomography (CBCT).
Lasso di tempo: Baseline, 6 months, 12 months after the implant placement
  1. Marginal Bone Level Measurements: It is the distance between a fixed reference point and the most apical point of connection between the implant surface and the bone. The reference point is the fixture-abutment interface.
  2. Bucco-lingual Alveolar Width: Width measurements will be made on tomographic slices perpendicular to the longitudinal axis of the alveolar crest at 1, 3 and 6 mm from summit of the alveolar crest.
Baseline, 6 months, 12 months after the implant placement

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Index
Lasso di tempo: first post-operative day, third day and after one week.

It will be evaluated using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes.

first post-operative day, third day and after one week.
Wound Healing Index (WHI)
Lasso di tempo: 1 and 2 weeks after surgery

score 1 indicates uneventful healing with no gingival edema, erythema suppuration, patient discomfort or flap dehiscence. Score 2 indicates uneventful healing with slight gingival edema, erythema, patient discomfort or flap dehiscence, but no suppuration. While score 3 indicates poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.

1 and 2 weeks after surgery
Implant Stability Measurements
Lasso di tempo: The RFA measurements will be made immediately after implant installation, and 3 months after implant placement before the prosthetic phase.

The stability of the implant will be evaluated with resonance frequency analysis (RFA). The measurements will be made with the Osstell device by connecting the transducer (smart peg) to the fixture. The mesiodistal and buccolingual direction will be measured and the mean implant stability quotient will be determined.

The RFA measurements will be made immediately after implant installation, and 3 months after implant placement before the prosthetic phase.
Peri-implant Probing Depth (PPD)
Lasso di tempo: Baseline, 6 months and 12 months post-operatively.

Using a calibrated plastic periodontal probe, the distance between marginal border of the gingiva and the tip of the probe will be measured in mm.

Baseline, 6 months and 12 months post-operatively.
Esthetic Evaluation
Lasso di tempo: At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively

Esthetic scoring index called pink esthetic score (PES) index will be used in the current study. Seven variables will be scored; mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process deficiency, soft tissue color, and texture of facial gingiva at the implant site. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. The PES index fulfilled important characteristics as inclusion of the peri-implant soft tissue and the restoration-inherent parameters.

At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Meran F Awad, MSc, Mansoura University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 novembre 2025

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

16 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

16 novembre 2025

Primo Inserito (Effettivo)

20 novembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 novembre 2026

Ultimo verificato

1 novembre 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • MPI with immediate implant

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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