Soft Tissue Augmentation Around Dental ImplantsNCT07018531
Vertical Soft Tissue Augmentation With Tent Pole Technique and Its Influence on Marginal Bone Loss Around Dental Implants
A study testing VST augmentation with TPT, TPT-PRF and TPT-PBM in people with Soft Tissue Augmentation Around Dental Implants, run by University of Santiago de Compostela at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Augmentation Around Dental Implants
- What is being tested?
- VST augmentation with TPT, TPT-PRF and TPT-PBM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Uncontrolled diabetes.
- Current pregnancy or breastfeeding status.
- Allergies to any products involved in the study.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Spain1 site
Oral Medicine, Oral Surgery and Implantology Unit (Medoralres), Faculty of Medicine and Dentistry, University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
Mario Pérez Sayáns, PhD, PhD, MDS, FDS, DDS, +34 626233504, mario.perez@usc.es
Tunisia1 site
Oral Health and Oral Rehabilitation Research Laboratory, LR12ES11, Faculty of Dental Medecine of Monastir, University of Monastir
Monastir, Monastir Governorate, 5019
Fakhreddine Alouane, DMD, Msc, PhD candidate, +34 615270185, alouenefakhri@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- VST augmentation with TPT, TPT-PRF, TPT-PBM, Group control: implant placement without TPT
- Keywords
- Dental Implants, Vertical Soft Tissue, Tent Pole Technique, Platelet-Rich Fibrin, Photobiomodulation, Marginal Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VST augmentation with TPTProcedure or surgery
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-PRFProcedure or surgery
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-PBMProcedure or surgery
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 TPTProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Tent pole technique | Experimental | Not described Receives: Procedure: VST augmentation with TPT |
| Tent pole technique with platelet-rich fibrin | Experimental | Not described Receives: Procedure: TPT-PRF |
| Tent pole technique with photobiomodulation | Experimental | Not described Receives: Procedure: TPT-PBM |
| Negative control group | Experimental | Not described Receives: Procedure: Group control: implant placement without TPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertical soft tissue height
Measured: 2 months , 4 months and 6 months
Marginal BoneLoss
Measured: 2 months, 4 months, 6 months
Secondary outcomes (3)
PPD
Pocket probing depth
Measured: 6 months
BOP
Bleeding on probing
Measured: 6 months
PI
Plaque Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Augmentation Around Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Galimplant Dental Implants
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018531
- Sponsor's protocol ID
- 412815
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data collected during our dental implant study will be made accessible to qualified researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07018531
- Acronym / sponsor ID
- 412815
- Keywords
- Dental Implants, Vertical Soft Tissue, Tent Pole Technique, Platelet-Rich Fibrin, Photobiomodulation, Marginal Bone Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Galimplant Dental Implants
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VST augmentation with TPTFor 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 or surgery | Tent pole technique |
| TPT-PRFIn 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 or surgery | Tent pole technique with platelet-rich fibrin |
| TPT-PBMThe 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 or surgery | Tent pole technique with photobiomodulation |
| Group control: implant placement without TPTThe 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. | Procedure or surgery | Negative control group |
Primary outcome
vertical soft tissue height
Time frame: 2 months , 4 months and 6 months
Marginal BoneLoss
Time frame: 2 months, 4 months, 6 months
3 secondary outcomes
PPD
Time frame: 6 months
BOP
Time frame: 6 months
PI
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Yes. data collected during our dental implant study will be made accessible to qualified researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VST augmentation with TPT, TPT-PRF and TPT-PBM in people with Soft Tissue Augmentation Around Dental Implants, run by University of Santiago de Compostela at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fakhreddine Alouane, DMD, Msc, PhD candidate (+34 615270185, alouenefakhri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical soft tissue height (time frame: 2 months , 4 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.