Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Papilla-preserving incisions performed during implant uncovering, without additional flap modification or grafting. |
|
| mLPPF group | Experimental | A modified labial pedicle papilla flap is advanced and sutured to reconstruct the peri-implant papilla, without connective tissue grafting. |
|
| mLPPF+dGG group | Experimental | A modified labial pedicle papilla flap is combined with placement of a de-epithelialized gingival graft harvested from the palate, sutured into the papillary region to enhance papilla reconstruction and increase mucosal thickness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papilla-preserving incision (Control) | Procedure | Standard papilla-preserving incision without additional flap modification or connective tissue grafting. This group serves as the control, receiving only routine surgical access for implant site management. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Papilla Height | 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. | Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Jemt Scores | Jemt scores will be assessed based on the degree of papilla fill, ranging from 0 (no papilla) to 4 (hypertrophic papilla). | Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). |
| Change in Crestal Mucosa Thickness |
Not provided
Inclusion Criteria:
Participants were eligible for inclusion if they:
Exclusion Criteria:
Participants were excluded if they:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cüneyt A Aral | Inonu University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inonu University Faculty of Dentistry | Malatya | 44210 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11699478 | Background | Choquet V, Hermans M, Adriaenssens P, Daelemans P, Tarnow DP, Malevez C. Clinical and radiographic evaluation of the papilla level adjacent to single-tooth dental implants. A retrospective study in the maxillary anterior region. J Periodontol. 2001 Oct;72(10):1364-71. doi: 10.1902/jop.2001.72.10.1364. | |
| 35186085 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Outcome assessors were blinded to group allocation. Papilla height, Jemt scores, and crestal mucosa thickness were measured using standardized intraoral photographs and STL files by independent examiners who were unaware of treatment assignment.
| Modified Labial Pedicle Papilla Flap (mLPPF) | Procedure | Surgical reconstruction of the peri-implant papilla using the modified labial pedicle papilla flap technique. The flap is mobilized and sutured without adjunctive grafting procedures. |
|
| Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG) | Procedure | Surgical reconstruction of the peri-implant papilla combining the modified labial pedicle papilla flap with placement of a de-epithelialized gingival graft (dGG) at the papillary region to enhance soft tissue volume and stability. |
|
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. |
| Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). |
| Correlation Between Papilla Height and Crestal Mucosa Thickness | The relationship between papilla height and crestal mucosa thickness will be analyzed to determine the impact of vertical soft tissue thickness on papilla stability. | Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3). |
| Gholami GA, Hariri S, Amid R, Roghanizadeh L, Kadkhodazadeh M, Mehdizadeh A, Youssefi N. Average and Maximum Papilla Heights around Dental Implants in the Anterior Maxillary Region: A Retrospective Clinical Study. Int J Dent. 2022 Feb 11;2022:4235946. doi: 10.1155/2022/4235946. eCollection 2022. |
| 1474471 | Background | Tarnow DP, Magner AW, Fletcher P. The effect of the distance from the contact point to the crest of bone on the presence or absence of the interproximal dental papilla. J Periodontol. 1992 Dec;63(12):995-6. doi: 10.1902/jop.1992.63.12.995. |
| 40136752 | Background | Botticelli D, Agabiti I, Yamada R, Maniwa N, Apaza Alccayhuaman KA, Nakajima Y. Identifying Key Factors in Papilla Growth Around Implants: Focus on Intraoral Negative Pressure. Dent J (Basel). 2025 Mar 13;13(3):124. doi: 10.3390/dj13030124. |
| 1521996 | Background | Beagle JR. Surgical reconstruction of the interdental papilla: case report. Int J Periodontics Restorative Dent. 1992;12(2):145-51. |