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

Official title

Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study

Overview

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.

Interventions

• Procedure 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.
• Procedure 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.

Primary outcome measures

• Change in Keratinized Tissue Width [Time frame: Baseline (second-stage surgery) to 12 months after surgery]
• Change in Peri-Implant Mucosal Thickness [Time frame: Baseline (second-stage surgery) to 12 months after surgery]

Secondary outcome measures (8)

• Pink Esthetic Score (PES) [Time frame: 3, 6, and 12 months after second-stage surgery]
• Change in Peri-Implant Soft Tissue Volume [Time frame: Baseline to 3, 6, and 12 months after second-stage surgery]
• Early Wound Healing Index [Time frame: 1 and 2 weeks after second-stage surgery]
• Plaque Index (PI) [Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery]
• Modified Sulcular Bleeding Index (mSBI) [Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery]
• Postoperative Pain Score [Time frame: 1 and 2 weeks after second-stage surgery]
• Postoperative Swelling Score [Time frame: 1 and 2 weeks after second-stage surgery]
• Change in Peri-Implant Bone Level [Time frame: Baseline to 12 months after second-stage surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07595211 · STUDY20252723

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗