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

NCT07018531 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Santiago de Compostela

Phase

Not applicable

Started

2025-07

Last updated

2025-06-17

Condition(s) studied

Soft Tissue Augmentation Around Dental Implants

Investigational drug(s) / intervention(s)

VST augmentation with TPTTPT-PRFTPT-PBMGroup control: implant placement without TPT

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.

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.

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants must be over 18 years of age. They should be legally capable of adhering to study protocols, which include maintaining proper oral hygiene, attending all scheduled follow-up visits, fully understanding the proposed surgical procedures, and signing the informed consent form. * single edentulous sites in the premolar and/or molar region of the mandible. * Vertical gingival thickness must be more than 1 mm and less than or equal to 2 mm. * A minimum of 2 mm of attached gingiva should be present on both the buccal and lingual sides of the implant sites. * Buccal bone thickness must be at least 1.5 mm. Exclusion Criteria: * Presence of general contraindications for dental implants or surgical interventions. * Heavy smoking, defined as more than 10 cigarettes daily, including pipe, vape or cigar use. * Poor oral hygiene, characterized by probing depths greater than 4 mm in adjacent teeth, and a full mouth plaque score (FMPS) or full mouth bleeding score (FMBS) exceeding 25% after the pre-treatment phase. * Guided bone regeneration at the implant site. * History of conditions or diseases that compromise bone metabolism (e.g. Paget's disease, osteoporosis) or current use of medications that may affect bone metabolism (e.g. bisphosphonates). * History of cancer or prior radiotherapy or chemotherapy treatments for malignancy. * Uncontrolled diabetes. * Current pregnancy or breastfeeding status. * Allergies to any products involved in the study.

Primary outcome measure(s)

vertical soft tissue height — 2 months , 4 months and 6 months
Marginal BoneLoss — 2 months, 4 months, 6 months

Trial sites (2)

Facility	City	Region	Status
Oral Medicine, Oral Surgery and Implantology Unit (Medoralres), Faculty of Medicine and Dentistry, University of Santiago de Compostela	Santiago de Compostela	A Coruña
Oral Health and Oral Rehabilitation Research Laboratory, LR12ES11, Faculty of Dental Medecine of Monastir, University of Monastir	Monastir	Monastir Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07018531 on ClinicalTrials.gov ↗ ← All trials in Spain