Modified Labial Pedicle Papilla Flap (mLPPF) With or Without De-epithelialized Gingival Graft (dG… (NCT07204353) | Clinical Trial Compass
CompletedNot Applicable
Modified Labial Pedicle Papilla Flap (mLPPF) With or Without De-epithelialized Gingival Graft (dGG) for Peri-implant Papilla Reconstruction
Turkey (Türkiye)80 participantsStarted 2021-02-01
Plain-language summary
This randomized controlled clinical trial aims to evaluate the effectiveness of two surgical techniques for peri-implant papilla reconstruction in single-tooth implants in the maxillary anterior and premolar regions. A total of 80 cases with papilla deficiency were allocated into three groups: papilla-preserving incisions only (Control), modified labial pedicle papilla flap (mLPPF), and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Clinical outcomes including papilla fill (Jemt scores), papilla height, and crestal mucosa thickness were assessed at baseline, immediately after surgery, two weeks postoperatively, and six months after final restoration. The primary goal is to determine whether combining connective tissue grafting with flap surgery provides superior and more stable papilla reconstruction compared with papilla preserving flap-only approaches.
Who can participate
Age range
22 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants were eligible for inclusion if they:
* Were between 22 and 45 years of age
* Voluntarily agreed to participate in the study
* Had good periodontal health defined as full-mouth bleeding on probing scores, with \<10%
* Had a single missing tooth in the maxillary anterior or premolar region with both neighbouring teeth present
* Had peri-implant papilla loss defined as JEMT score \<3
Exclusion Criteria:
* Participants were excluded if they:
* Were smokers
* Had any systemic condition that could potentially influence study outcomes or implant success, such as diabetes mellitus, osteoporosis, or a history of radiotherapy
* Were undergoing pharmacological treatment that could affect the results, including the use of bisphosphonates, immunosuppressive agents, or regular analgesic medications
* Had clinical signs of peri-implant mucositis or peri-implantitis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Papilla Height
Timeframe: Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).