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.
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.
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
Parallel
Apically Positioned Flap (APF)
Procedure/SurgeryA 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/SurgeryA 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.
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.
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.
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.
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.
Early Wound Healing Index
Early wound healing will be assessed using a standardized healing index based on tissue color, bleeding, granulation tissue, and epithelialization.
Plaque Index (PI)
Oral hygiene status will be assessed using the plaque index based on clinical examination at peri-implant sites.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
