Dental ImplantNCT07595211
Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery
A study testing Apically Positioned Flap (APF) and Rolled Flap Technique (RFT) in people with Dental Implant, run by Ohio State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Apically Positioned Flap (APF) and Rolled Flap Technique (RFT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Apically Positioned Flap (APF), Rolled Flap Technique (RFT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apically Positioned Flap (APF)Procedure or surgery
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.
Rolled Flap Technique (RFT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Rolled Flap Technique (RFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (second-stage surgery) to 12 months after surgery
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months after second-stage surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595211
- Sponsor's protocol ID
- STUDY20252723
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07595211
- Acronym / sponsor ID
- STUDY20252723
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Apically Positioned Flap (APF) | Active comparator | Procedure: 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. |
| Rolled Flap Technique (RFT) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Apically Positioned Flap (APF) |
| 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. | Procedure or surgery | Rolled Flap Technique (RFT) |
Primary outcome
Change in Keratinized Tissue Width
Time frame: 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
Time frame: 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.
8 secondary outcomes
Pink Esthetic Score (PES)
Time frame: 3, 6, and 12 months after second-stage surgery
Change in Peri-Implant Soft Tissue Volume
Time frame: Baseline to 3, 6, and 12 months after second-stage surgery
Early Wound Healing Index
Time frame: 1 and 2 weeks after second-stage surgery
Plaque Index (PI)
Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
Modified Sulcular Bleeding Index (mSBI)
Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
Postoperative Pain Score
Time frame: 1 and 2 weeks after second-stage surgery
Postoperative Swelling Score
Time frame: 1 and 2 weeks after second-stage surgery
Change in Peri-Implant Bone Level
Time frame: Baseline to 12 months after second-stage surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Apically Positioned Flap (APF) and Rolled Flap Technique (RFT) in people with Dental Implant, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Bodnar, DDS (6142924641, bodnar.61@buckeyemail.osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Keratinized Tissue Width (time frame: Baseline (second-stage surgery) to 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.