Modified Labial Pedicle Papilla Flap (mLPPF) With or Without De-epithelialized Gingival Graft (dGG) for Peri-implant Papilla Reconstruction
- Conditions
- Peri-Implant Papilla Deficiency
- Registration Number
- NCT07204353
- Lead Sponsor
- Cuneyt Asim Aral
- Brief 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.
- Detailed Description
Peri-implant papilla deficiency remains one of the most challenging aspects of achieving esthetic success in implant dentistry, particularly in the anterior maxilla where soft tissue harmony plays a pivotal role. Despite the development of several surgical and prosthetic techniques, no universally accepted gold standard procedure or biomaterial has been established for papilla reconstruction.
This randomized controlled clinical trial was designed to investigate the clinical outcomes of two surgical approaches for peri-implant papilla reconstruction: the modified labial pedicle papilla flap (mLPPF) performed alone, and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Patients presenting with single-tooth missing sites in the maxillary anterior or premolar regions, associated with papilla loss, were recruited. A total of 80 cases were allocated to three groups:
Control group - papilla-preserving incisions only,
mLPPF group - surgical papilla reconstruction with a modified pedicle flap,
mLPPF+dGG group - flap reconstruction combined with a connective tissue graft harvested and de-epithelialized from the palate.
Clinical outcomes included Jemt papilla index scores, papilla height (measured using standardized intraoral photography and STL files), and crestal mucosa thickness. Measurements were obtained at baseline (T0), immediately after surgery (T1), two weeks postoperatively (T2), and six months after prosthetic restoration (T3).
The primary hypothesis was that combining flap techniques with dGG would result in superior papilla fill and long-term tissue stability compared with flap-only or incision-only techniques. Statistical analyses confirmed that the mLPPF+dGG group demonstrated significantly higher Jemt scores, papilla height, and crestal mucosa thickness from the early postoperative period through the six-month follow-up. Moreover, strong positive correlations were identified between papilla height and crestal mucosa thickness, supporting the biological interplay between vertical mucosal thickness and papillary stability.
The trial provides randomized controlled evidence that the use of de-epithelialized gingival grafts in combination with pedicle flap surgery is a predictable and effective method for peri-implant papilla reconstruction, with potential implications for clinical practice in esthetically demanding cases.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Papilla Height Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). Papilla height will be measured as the perpendicular distance from the papilla tip to a line connecting the zenith points of the two adjacent teeth, using standardized intraoral photographs and STL-based digital analysis.
- Secondary Outcome Measures
Name Time Method Change in Jemt Scores Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). Jemt scores will be assessed based on the degree of papilla fill, ranging from 0 (no papilla) to 4 (hypertrophic papilla).
Change in Crestal Mucosa Thickness Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). Crestal mucosa thickness will be measured at the mid-buccal aspect using a standardized endodontic reamer with silicone stopper under local anesthesia. Measurements will be confirmed through STL-based analysis.
Correlation Between Papilla Height and Crestal Mucosa Thickness Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). The relationship between papilla height and crestal mucosa thickness will be analyzed to determine the impact of vertical soft tissue thickness on papilla stability.
Trial Locations
- Locations (1)
Inonu University Faculty of Dentistry
Malatya, Turkey (Türkiye)
Inonu University Faculty of DentistryMalatya, Turkey (Türkiye)