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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: Apically Positioned Flap (APF); Procedure: Rolled Flap Technique (RFT)

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia Bodnar, DDS; Phone Number: 6142924641; Email: bodnar.61@buckeyemail.osu.edu
• Study Contact Backup: Name: Guo-Liang Cheng, DDS, MS; Phone Number: 6142924641; Email: cheng.712@osu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score (PES)	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	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	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)	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)	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	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	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	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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY20252723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No