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

NCT07595211 | Not Yet Recruiting

• 1 other identifier: STUDY20252723
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (2)

• Change in Keratinized Tissue Width

  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

  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

Secondary Outcomes (8)

• Pink Esthetic Score (PES)

  3, 6, and 12 months after second-stage surgery

• Change in Peri-Implant Soft Tissue Volume

  Baseline to 3, 6, and 12 months after second-stage surgery

• Early Wound Healing Index

  1 and 2 weeks after second-stage surgery

• Plaque Index (PI)

  1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery

• Modified Sulcular Bleeding Index (mSBI)

  1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery

Study Arms (2)

Apically Positioned Flap (APF)

ACTIVE COMPARATOR

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.

Procedure: Apically Positioned Flap (APF)

Rolled Flap Technique (RFT)

EXPERIMENTAL

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.

Procedure: Rolled Flap Technique (RFT)

Interventions

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.

Apically Positioned Flap (APF)

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.

Rolled Flap Technique (RFT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Central Study Contacts

Olivia Bodnar, DDS

CONTACT

6142924641; bodnar.61@buckeyemail.osu.edu

Guo-Liang Cheng, DDS, MS

CONTACT

6142924641; cheng.712@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized, split-mouth clinical trial. Each participant has two implants and receives both interventions during second-stage surgery, with one implant site randomly assigned to an apically positioned flap and the other to a rolled flap technique. This within-subject design allows direct comparison of peri-implant soft tissue outcomes while controlling for patient-level variability.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05