Papilla Reconstruction
Conditions
Keywords
De-epithelialized gingival graft, Titanium-prepared Platelet-Rich Fibrin, Han and Takei technique, interdental papilla loss
Brief summary
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) has emerged as a promising biomaterial in periodontal regenerative procedures. The aim of this study will be to compare the clinical effectiveness of de-epithelialized gingival grafts (DGG) and T-PRF in the reconstruction of deficient interdental papillae using the tunnel technique. Methods: A total of 34 patients presenting with 115 Class I and II interdental papilla defects will be enrolled in this study. Interdental papilla reconstruction will be performed using the tunnel technique in combination with either DGG or T-PRF. Demographic characteristics (age and sex), dentogingival variables (tooth shape, papilla location, jaw type, and papilla loss classification), and clinical parameters will be recorded. Clinical assessments will include probing depth (PD), gingival index (GI), plaque index (PI), gingival thickness (GT), keratinized tissue height (KTH), black triangle width (BTW), black triangle height (BTH), papilla fill percentage (%PF), and black triangle area (BTA). All clinical parameters will be assessed at baseline and at 1, 3, and 6 months following surgery.
Detailed description
This randomized controlled clinical trial aims to evaluate the clinical efficacy of two autogenous grafting materials, de-epithelialized gingival graft (DGG) and titanium-prepared platelet-rich fibrin (T-PRF), when used in combination with the tunnel technique for interdental papilla reconstruction (IPR). Interdental papilla defects may cause esthetic concerns, food impaction, and phonetic difficulties. Several surgical and non-surgical methods have been proposed for IPR. Connective tissue grafts (CTG) are considered the gold standard in many periodontal procedures; however, they require a second surgical site and are associated with increased patient discomfort. As alternatives, several types of PRF have been developed; however, T-PRF demonstrates superior properties, including improved biocompatibility and prolonged growth factor release. The study is designed as a parallel-group randomized controlled trial. Thirty-four participants with Class I or II interdental papilla defects were included and randomly assigned to one of two groups: Control Group: tunnel technique combined with DGG Test Group: tunnel technique combined with T-PRF membrane Surgical procedures were performed by the same operator, while measurements were obtained by a blinded examiner. Clinical parameters will be evaluated preoperatively and at 1, 3, and 6 months postoperatively. Inclusion criteria include participants aged 25-70 years with papilla loss in the anterior maxilla or mandible, systemically healthy, non-smokers, and with no previous surgery in the target area. Exclusion criteria include smoking, systemic diseases, pregnancy or breastfeeding, and poor compliance with follow-up visits. Prior to the surgical procedure, all participants received Phase I periodontal therapy, including comprehensive oral hygiene instructions. Participants were re-evaluated during follow-up visits, and those meeting the inclusion criteria were subsequently enrolled in the surgical phase. Surgical Procedure The surgical procedure involves papilla reconstruction using the tunnel technique. Sulcular and horizontal incisions are made to create a half-thickness tunnel flap. De-epithelialized gingival grafts or T-PRF membranes are prepared according to standardized protocols and placed into the prepared papillary voids. Grafts are stabilized using guiding sutures, and tension-free closure of the flap is achieved. Postoperative care includes pain management, antimicrobial therapy, and oral hygiene instructions. Measurement of Demographic, Dentogingival, and Clinical Parameters Demographic and dentogingival data, including age, gender, crown shape, papilla classification, jaw type, and papilla area, will be recorded. Clinical parameters assessed preoperatively and at follow-up include probing depth, gingival index, plaque index, gingival thickness, keratinized tissue height, black triangle height and width, papilla fill percentage, and black triangle area. Standardized measurement techniques and calibrated instruments will be used to ensure accuracy and reproducibility. Statistical Analysis Data will be analyzed using Statistical Package for the Social Sciences and Jamovi software application. Normality will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. Between-group comparisons will use Mann-Whitney U test, and categorical data will be evaluated using Fisher's Exact Test or Yates correction. Repeated measures will be analyzed using Robust ANOVA. Statistical significance will be set at p \< 0.05.
Interventions
PROCEDUREDe-epithelialized gingival graft
Papilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. De-epithelialized gingival graft material was inserted from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. It was then positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure.
Papilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. A Titanium-Prepared Platelet-Rich Fibrin (T-PRF) graft was introduced from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. The graft was positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure.
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 25 and 70 years. * Presence of papilla loss in the anterior region of the maxilla or mandible. * Classification of papilla loss as Class 1 or 2 * Absence of systemic diseases. * No bleeding disorders that could interfere with the surgery. * Non-smoker and non-alcohol consumer. * Not pregnant or breastfeeding. * Absence of fillings, prostheses, or root canal treatments in the relevant teeth. * No prior surgical interventions in the target area.
Exclusion criteria
* Smoking or alcohol consumption. * Presence of systemic diseases * Patients who did not attend postoperative follow-up appointments regularly. * Pregnant or breastfeeding individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| black triangle height | preoperative and postoperative (1, 3, 6 months) | The distance between the lowest point of the interdental contact area of teeth adjacent to the papilla and the highest point of the gingival papilla was measured. |
| black triangle width | preoperative and postoperative (1, 3, 6 months) | The distance between the contact points of the papilla apex and the two adjacent teeth. |
| black triangle area | preoperative and postoperative (1, 3, 6 months) | BTA was calculated as the area between the interdental contact points of the teeth and the gingival papilla using the formula: BTA= (BTH x BTW) /2 |
| % Percentage fill | preoperative and postoperative 6 months | The percentage change in black triangle height between two time intervals was calculated using the formula: %PD=(tendBTH - tfirstBTH) /tendBTH x100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| keratinized tissue height | preoperative and postoperative (1, 3, 6 months) | The distance between the interdental papilla apex and the mucogingival junction was measured using a periodontal probe |
| Gingival thickness | preoperative and postoperative (1, 3, 6 months) | Gingival thickness was measured at the center of the interdental papilla area. A No. 20 spreader was inserted perpendicularly into the gingival tissue at a distance of 3 mm from the papilla apex until contact with the bone surface, and tissue thickness was calculated using a stopper. Measurements were taken with a digital caliper for precision. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMakbule CAN, Res. asst.
Pamukkale University Faculty of Dentistry, Denizli, Turkey
Outcome results
None listed