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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia Bodnar, DDS | Contact | 6142924641 | bodnar.61@buckeyemail.osu.edu | |
| Guo-Liang Cheng, DDS, MS | Contact | 6142924641 | cheng.712@osu.edu |
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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.
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| 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. |
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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 |