Dental Implant
Conditions
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.
Interventions
PROCEDUREApically 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.
PROCEDURERolled 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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Keratinized Tissue Width | 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. |
| Change in Peri-Implant Mucosal Thickness | 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
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Score (PES) | 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. |
| Change in Peri-Implant Soft Tissue Volume | 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. |
| Early Wound Healing Index | 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. |
| Plaque Index (PI) | 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. |
| Modified Sulcular Bleeding Index (mSBI) | 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. |
| Postoperative Pain Score | 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. |
| Postoperative Swelling Score | 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. |
| Change in Peri-Implant Bone Level | 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. |
Contacts
CONTACTOlivia Bodnar, DDS
CONTACTGuo-Liang Cheng, DDS, MS
Outcome results
None listed