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

NCT07018531 | Not Yet Recruiting

• 1 other identifier: 412815
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Soft Tissue Augmentation Around Dental Implants

Keywords

Dental Implants; Vertical Soft Tissue; Tent Pole Technique; Platelet-Rich Fibrin; Photobiomodulation; Marginal Bone Loss

Outcome Measures

Primary Outcomes (2)

• vertical soft tissue height

  2 months , 4 months and 6 months

• Marginal BoneLoss

  2 months, 4 months, 6 months

Secondary Outcomes (3)

• PPD

  6 months

• BOP

  6 months

• PI

  6 months

Study Arms (4)

Tent pole technique

EXPERIMENTAL

Procedure: VST augmentation with TPT

Tent pole technique with platelet-rich fibrin

EXPERIMENTAL

Procedure: TPT-PRF

Tent pole technique with photobiomodulation

EXPERIMENTAL

Procedure: TPT-PBM

Negative control group

EXPERIMENTAL

Procedure: Group control: implant placement without TPT

Interventions

VST augmentation with TPT PROCEDURE

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.

Tent pole technique

TPT-PRF PROCEDURE

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.

Tent pole technique with platelet-rich fibrin

TPT-PBM PROCEDURE

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.

Tent pole technique with photobiomodulation

Group control: implant placement without TPT PROCEDURE

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.

Negative control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Galimplant Dental Implants: collaborator

Study Sites (2)

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

Santiago de Compostela, A Coruña, 15782, Spain

Location

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

Monastir, Monastir Governorate, 5019, Tunisia

Location

MeSH Terms

Interventions

9 alpha,11 alpha,15 alpha-trihydroxy-16-phenoxy-17,18,19,20-tetranorprosta-4,5,13-trienoic acid

Central Study Contacts

Fakhreddine Alouane, DMD, Msc, PhD candidate

CONTACT

+34 615270185; alouenefakhri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Oral Medicine, Oral Surgery and Implantology, Faculty of Dental Medicine, University of Santiago de Compostela

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1); ES (1)