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Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery

12 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

16

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Guo-Liang Cheng, DDS, MS
  • Numéro de téléphone: 6142924641
  • E-mail: cheng.712@osu.edu

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Patients between the ages of 18-80.
  2. Non-smokers or former smokers with at least a 5-year successful cessation history.
  3. 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.
  4. Patients who had, or plan to have, 2 non-adjacent implants of the same system placed under a two-stage implant protocol.
  5. The diameter discrepancy of the 2 target implants must be less than 1 mm.

Exclusion Criteria:

  1. Current smokers, or smokers who have quit <5 years prior to study entry.
  2. Pregnant or lactating women
  3. Patients with substance or alcohol abuse
  4. Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
  5. Other systemic conditions or medication affecting wound healing.
  6. Poor plaque control with plaque score > 20%
  7. Active/untreated odontogenic and periodontal infections
  8. Implants placed, or planned to be placed, with one-stage implant protocol.
  9. The diameter discrepancy of the 2 target implants is equal to or greater than 1 mm (≥ 1 mm).
  10. Implants showing signs of early peri-implant bone loss or infection.
  11. Severe loss of keratinized tissue (> 50%) at the implant site
  12. Non-English speaking individuals for studies involving informed consent.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Procédure: Apically Positioned Flap (APF)
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.
Expérimental: 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.
Procédure: Rolled Flap Technique (RFT)
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Keratinized Tissue Width
Délai: 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.
Baseline (second-stage surgery) to 12 months after surgery
Change in Peri-Implant Mucosal Thickness
Délai: Baseline (second-stage surgery) to 12 months after surgery
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.
Baseline (second-stage surgery) to 12 months after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pink Esthetic Score (PES)
Délai: 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.
3, 6, and 12 months after second-stage surgery
Change in Peri-Implant Soft Tissue Volume
Délai: 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
Early Wound Healing Index
Délai: 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.
1 and 2 weeks after second-stage surgery
Plaque Index (PI)
Délai: 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.
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
Modified Sulcular Bleeding Index (mSBI)
Délai: 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.
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
Postoperative Pain Score
Délai: 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.
1 and 2 weeks after second-stage surgery
Postoperative Swelling Score
Délai: 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.
1 and 2 weeks after second-stage surgery
Change in Peri-Implant Bone Level
Délai: 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.
Baseline to 12 months after second-stage surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ohio State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 juin 2026

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

30 juin 2028

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

12 mai 2026

Première publication (Réel)

19 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • STUDY20252723

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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