NCT07018531

Vertical Soft Tissue Augmentation With Tent Pole Technique and Its Influence on Marginal Bone Loss Around Dental Implants

Vertical Soft Tissue Augmentation Using the Tent-Pole Technique With Adjunctive Therapies and Its Influence on Marginal Bone Loss Around Dental Implants: A Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of the tent pole technique in vertical peri-implant soft tissue augmentation and to assess its impact on marginal bone loss. Additionally, the adjunctive use of platelet-rich fibrin and photobiomodulation will be explored to determine their influence on the clinical outcomes of this procedure.

Detailed description

Thin vertical soft tissues (VST) around dental implants pose a clinical challenge due to their strong association with marginal bone loss (MBL). Current evidence suggests that a minimum of 3 mm of VST height is essential to ensure peri-implant bone stability. Several techniques have been proposed to augment soft tissue thickness and reduce MBL, including connective tissue grafts, membranes, platelet-rich fibrin (PRF), and the Tent Pole Technique (TPT), which uses a 2 mm healing abutment to tent the soft tissue. This randomized controlled clinical trial aims to assess the effectiveness of the TPT when performed simultaneously with implant placement, in comparison to a non-intervention control group, for vertical soft tissue augmentation. Additionally, the study evaluates the impact of two adjunctive therapies: photobiomodulation (PBM) and PRF combined with TPT. In fact, PBM involves the application of low-level laser therapy at a wavelength of 630 nm to the occlusal site immediately after surgery and again at day 7, with the goal of enhancing cellular activity, accelerating healing, and promoting soft tissue regeneration. PRF, an autologous concentrate rich in growth factors, is used to fill the space created by the healing abutment in the TPT, further supporting tissue regeneration. The study includes four groups: TPT alone, TPT combined with PBM, TPT combined with PRF, and a control group without soft tissue intervention. The hypothesis is that TPT is effective in increasing vertical soft tissue thickness and maintaining marginal bone levels, and that its combination with either PBM or PRF may further enhance clinical outcomes both in the short and long term.

Conditions

• Soft Tissue Augmentation Around Dental Implants

Interventions

Type	Name	Description
PROCEDURE	VST augmentation with TPT	For TPT group, vertical soft tissue augmentation will be performed simultaneously with implant placement using a 2 mm healing abutment. Than, to ensure tension-free primary closure, mucoperiosteal flaps will be mobilized through vertical releasing incisions. Wound closure will be achieved using horizontal mattress sutures, followed by simple interrupted sutures for optimal tissue adaptation. The healing abutment will act as a mechanical support to maintain space and prevent soft tissue collapse. This tented space is expected to allow blood to accumulate, clot, and gradually reorganize into connective tissue, thereby promoting an increase in vertical soft tissue thickness around the implant. After 2 months , the initial 2-mm healing abutment will be removed, and a 4 mm healing abutment will be placed by mading a small semilunar incision without touching the bone.
PROCEDURE	TPT-PRF	In the PRF group, the same surgical protocol as the TPT group will be followed. However, prior to wound closure, the tented space surrounding the healing abutment will be filled with PRF membranes.
PROCEDURE	TPT-PBM	The PBM group will follow the same surgical protocol as the TPT group. In addition, this group will receive photobiomodulation therapy using red-light irradiation at a wavelength of 630 nm, applied to the occlusal site immediately after surgery and repeated after 7 days.
PROCEDURE	Group control: implant placement without TPT	The negative control group will consist of patients randomly selected from the recruited population, in accordance with the study's inclusion criteria. Participants in this group will not receive any intervention aimed at VST augmentation during implant placement. This will allow for a clear assessment of the effect of the TPT on VST gain and its impact on MBL. In accordance with ethical guidelines, patients in the control group will undergo VST augmentation at a second stage, prior to the initiation of the prosthetic phase.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-06-12
• Last updated: 2025-06-17

Locations

2 sites across 2 countries: Spain, Tunisia