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NOT YET RECRUITING
NCT07018531
NA

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

Sponsor: University of Santiago de Compostela

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2025-07

Completion Date

2026-08

Last Updated

2025-06-17

Healthy Volunteers

No

Interventions

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.

Locations (2)

Oral Medicine, Oral Surgery and Implantology Unit (Medoralres), Faculty of Medicine and Dentistry, University of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Oral Health and Oral Rehabilitation Research Laboratory, LR12ES11, Faculty of Dental Medecine of Monastir, University of Monastir

Monastir, Monastir Governorate, Tunisia