Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery
12 maggio 2026 aggiornato da: Ohio State University
Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study
Patients are being asked to consider joining a research study that looks at two different ways dentists uncover dental implants during a small gum surgery. To join this study, Patients must have two dental implants that are ready to be uncovered. Both uncovering methods used in this research are normal, safe procedures that dentists already use every day. The purpose of this study is to learn which method helps the gums heal better, stay thicker, and look more natural over time.
If patients decide to participate, the dentist will use one method on one implant and the other method on the second implant so we can compare how each implant heals. The study lasts about one year and includes the uncovering surgery plus scheduled follow-up visits. At these visits, the dentist will gently measure your gums, take pictures, take routine dental X-rays, and use a small camera scanner to check how the gum tissue changes. Patients will also be asked to rate any pain or swelling after surgery.
Patients may have soreness, swelling, or minor bleeding-these are the same risks patients would have during normal implant care. Patients may or may not personally benefit, but the extra monitoring may help us track the healing closely, and patients' participation can help dentists improve care for future patients.
Patients can receive regular implant treatment without joining the study. The goal of this summary is to help you think about the pros and cons and decide what feels right for patients.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
16
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.
Contatto studio
- Nome: Olivia Bodnar, DDS
- Numero di telefono: 6142924641
- Email: bodnar.61@buckeyemail.osu.edu
Backup dei contatti dello studio
- Nome: Guo-Liang Cheng, DDS, MS
- Numero di telefono: 6142924641
- Email: cheng.712@osu.edu
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
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Patients between the ages of 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction or cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients who had, or plan to have, 2 non-adjacent implants of the same system placed under a two-stage implant protocol.
- The diameter discrepancy of the 2 target implants must be less than 1 mm.
Exclusion Criteria:
- Current smokers, or smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medication affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
- Implants placed, or planned to be placed, with one-stage implant protocol.
- The diameter discrepancy of the 2 target implants is equal to or greater than 1 mm (≥ 1 mm).
- Implants showing signs of early peri-implant bone loss or infection.
- Severe loss of keratinized tissue (> 50%) at the implant site
- Non-English speaking individuals for studies involving informed consent.
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: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Apically Positioned Flap (APF)
During implant second-stage surgery, a crestal incision with vertical releases is used to elevate a flap that is repositioned apically and buccally to increase the width of keratinized tissue around the implant, followed by placement of a healing abutment and suturing.
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A flap design used during implant second-stage surgery in which a crestal incision with vertical releases is performed, and the flap is repositioned apically and buccally to increase the width of keratinized tissue around the implant.
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Sperimentale: Rolled Flap Technique (RFT)
During implant second-stage surgery, a full-thickness flap is elevated, and a pedicled connective tissue portion is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness, followed by placement of a healing abutment and suturing.
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A flap design used during implant second-stage surgery in which a pedicled connective tissue portion of the flap is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Keratinized Tissue Width
Lasso di tempo: Baseline (second-stage surgery) to 12 months after surgery
|
Keratinized tissue width will be measured clinically in millimeters at the mid-buccal aspect of the implant using a periodontal probe at prespecified follow-up visits.
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Baseline (second-stage surgery) to 12 months after surgery
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Change in Peri-Implant Mucosal Thickness
Lasso di tempo: Baseline (second-stage surgery) to 12 months after surgery
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Peri-implant mucosal thickness will be assessed by superimposing serial intraoral scan data to quantify changes in buccal soft tissue thickness at implant sites over time.
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Baseline (second-stage surgery) to 12 months after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pink Esthetic Score (PES)
Lasso di tempo: 3, 6, and 12 months after second-stage surgery
|
Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score based on standardized clinical photographs, assessing papilla, tissue contour, color, and texture.
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3, 6, and 12 months after second-stage surgery
|
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Change in Peri-Implant Soft Tissue Volume
Lasso di tempo: Baseline to 3, 6, and 12 months after second-stage surgery
|
Three-dimensional soft tissue volume changes will be quantified by superimposing serial intraoral scan data obtained at baseline and follow-up visits.
|
Baseline to 3, 6, and 12 months after second-stage surgery
|
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Early Wound Healing Index
Lasso di tempo: 1 and 2 weeks after second-stage surgery
|
Early wound healing will be assessed using a standardized healing index based on tissue color, bleeding, granulation tissue, and epithelialization.
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1 and 2 weeks after second-stage surgery
|
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Plaque Index (PI)
Lasso di tempo: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Oral hygiene status will be assessed using the plaque index based on clinical examination at peri-implant sites.
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1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
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Modified Sulcular Bleeding Index (mSBI)
Lasso di tempo: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Peri-implant soft tissue inflammation will be assessed using the modified sulcular bleeding index during clinical examination.
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1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
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Postoperative Pain Score
Lasso di tempo: 1 and 2 weeks after second-stage surgery
|
Participant-reported pain will be measured using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
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1 and 2 weeks after second-stage surgery
|
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Postoperative Swelling Score
Lasso di tempo: 1 and 2 weeks after second-stage surgery
|
Participant-reported swelling will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater perceived swelling.
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1 and 2 weeks after second-stage surgery
|
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Change in Peri-Implant Bone Level
Lasso di tempo: Baseline to 12 months after second-stage surgery
|
Peri-implant marginal bone levels will be assessed using standardized periapical radiographs and compared between baseline and follow-up.
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Baseline to 12 months after second-stage surgery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Stimato)
30 giugno 2026
Completamento primario (Stimato)
30 giugno 2028
Completamento dello studio (Stimato)
30 giugno 2028
Date di iscrizione allo studio
Primo inviato
12 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
12 maggio 2026
Primo Inserito (Effettivo)
19 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- STUDY20252723
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
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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