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NCT Number: NCT07595211

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

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.

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Key information

Conditions

Dental Implant

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apically Positioned Flap (APF)

Procedure

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.

Rolled Flap Technique (RFT)

Procedure

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 outcomes

  1. Change in Keratinized Tissue Width

    Time frame: 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.

  2. Change in Peri-Implant Mucosal Thickness

    Time frame: 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.

Secondary outcomes

  1. Pink Esthetic Score (PES)

    Time frame: 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.

  2. Change in Peri-Implant Soft Tissue Volume

    Time frame: 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.

  3. Early Wound Healing Index

    Time frame: 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.

  4. Plaque Index (PI)

    Time frame: 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.

  5. Modified Sulcular Bleeding Index (mSBI)

    Time frame: 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.

  6. Postoperative Pain Score

    Time frame: 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.

  7. Postoperative Swelling Score

    Time frame: 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.

  8. Change in Peri-Implant Bone Level

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guo-Liang Cheng, DDS, MS

CONTACT

[email protected]

6142924641

Olivia Bodnar, DDS

CONTACT

[email protected]

6142924641

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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