GingivaNCT07294287
Impact of Microneedling on the Gingival Tissue Surrounding Implant Supported Fixed Restoration.
A study testing Microneedling Combined with Accelerated Growth Factor (AGF) and Accelerated Growth Factor (AGF) Injection Only in people with Gingiva and Dental Implants, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to evaluate the effect of microneedling with and without accelerated growth factor (AGF) injection on gingival tissue surrounding implant-supported fixed restorations. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Gingiva, Dental Implants
- What is being tested?
- Microneedling Combined with Accelerated Growth Factor (AGF) and Accelerated Growth Factor (AGF) Injection Only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2024to 5 Jan 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 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-34 years
- Thin gingival biotype ( 0.8- 1mm GT at maxillary anterior teeth)
- Non-smokers
- Plaque index (PI) score 0-1
- No bleeding on probing
- No malocclusion or crowding affecting implant site
Who cannot join
- Active orthodontic treatment
- Previous periodontal surgery at study sites
- Systemic diseases affecting healing
- Use of anticoagulants or drugs causing gingival enlargement
- Mucogingival stress or bruxism
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527
About this study
This randomized clinical trial aims to evaluate the effect of microneedling with and without accelerated growth factor (AGF) injection on gingival tissue surrounding implant-supported fixed restorations. The peri-implant soft tissue phenotype is an important determinant of long-term implant stability and esthetic success. Patients with thin gingival biotype are more susceptible to mucosal recession, soft tissue transparency, and peri-implant complications. Enhancing gingival thickness and keratinized tissue width using minimally invasive methods can improve esthetic and biological outcomes.
Microneedling has recently been proposed as a simple and minimally invasive approach that stimulates local healing by inducing controlled micro-injury. It triggers angiogenesis and the release of intrinsic growth factors that promote soft tissue regeneration. Accelerated Growth Factor (AGF) is an autologous platelet concentrate obtained through a single-step centrifugation technique. It contains a high concentration of platelet-derived and vascular growth factors that enhance tissue repair and collagen synthesis. Combining microneedling with AGF may therefore produce synergistic effects, improving the soft tissue phenotype and peri-implant mucosal stability.
Read more
The study will include 20 participants aged 18-34 years with thin gingival biotype (0.8-1 mm) around maxillary anterior implants. Participants will be randomly assigned to one of two groups:
- AGF group: AGF injection alone.
- Microneedling + AGF group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, followed by AGF injection (0.2-0.3 mL per site).
Clinical parameters including gingival thickness (GT), keratinized tissue width (KTW), probing depth (PD), and bleeding index (BI) will be recorded at baseline, 3 months, and 6 months. All participants will receive standardized zirconia restorations following osseointegration. Statistical analysis will include intra- and inter-group comparisons, with significance set at p < 0.05.
The study is expected to clarify whether combining microneedling with AGF enhances peri-implant soft tissue thickness more effectively than AGF alone. If successful, this combined minimally invasive approach may offer a practical and biologically based technique to improve soft tissue health and esthetics around dental implants.
Read the detailed description
The peri-implant mucosa plays a crucial role in the biological and esthetic stability of dental implants. A thin gingival biotype is often associated with soft tissue recession, marginal bone loss, and esthetic compromise. Conventional augmentation techniques such as connective tissue grafting are effective but involve additional morbidity, donor site discomfort, and variable esthetic results. This study investigates a minimally invasive approach combining microneedling and accelerated growth factor (AGF) injection to enhance the gingival tissue phenotype around implant-supported restorations.
Microneedling is based on creating controlled micro-perforations in the soft tissue surface using fine needles. These micro-injuries induce a natural wound healing cascade that includes platelet activation, release of endogenous growth factors, angiogenesis, and fibroblast stimulation. The process enhances collagen deposition and epithelial thickening, which may increase the overall gingival thickness and keratinized tissue width.
AGF is an autologous blood-derived product obtained by a standardized single-step centrifugation technique that separates platelet-rich fractions containing high levels of biologically active molecules such as PDGF, VEGF, and TGF-β. These factors promote tissue regeneration and accelerate wound healing. Injecting AGF into peri-implant mucosa provides a reservoir of growth factors that stimulate fibroblast activity, improve tissue vascularity, and enhance collagen formation.
The hypothesis of this trial is that combining microneedling with AGF will yield superior soft tissue enhancement compared to AGF alone.
Study Design
This is a prospective, randomized, single-blinded, parallel-arm interventional clinical trial. 20 sites for patients aged 18-34 years with thin gingival biotype (0.8-1mm) in the maxillary anterior region will be included. Participants will be randomly assigned to two groups using a computer-generated random sequence:
- AGF Group: AGF injection only.
- Microneedling + AGF Group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, immediately followed by AGF injection (0.2-0.3 mL per site).
Methodology
The study follows five sequential phases:
- Pre-surgical Phase: Clinical and radiographic evaluation, oral hygiene instructions, baseline measurement of GT, KTW, PD, and BI.
- Surgical Phase: Implant placement in the maxillary anterior region followed by 3-4 months of osseointegration.
- Intervention Phase: Randomized treatment application after healing.
- Restorative Phase: Fabrication and cementation of standardized zirconia crowns.
- Follow-up Phase: Assessment of all parameters at baseline, 3, and 6 months. Outcome Measures
- Primary Outcome: Gingival thickness (GT) at baseline, 3, and 6 months.
- Secondary Outcomes: Keratinized tissue width (KTW), probing depth (PD), and bleeding index (BI).
Statistical Analysis Data will be analyzed using SPSS software (IBM). Paired and unpaired t-tests will compare intra- and inter-group differences. The significance level will be set at p < 0.05.
- Conditions
- Gingiva, Dental Implants
- Being tested
- Microneedling Combined with Accelerated Growth Factor (AGF), Accelerated Growth Factor (AGF) Injection Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling Combined with Accelerated Growth Factor (AGF)Procedure or surgery
Participants in this arm received microneedling around the peri-implant mucosa in the maxillary anterior region using sterile disposable glucometer lancets under aseptic conditions. Repeated micro-perforations were created circumferentially until pinpoint bleeding appeared. Immediately afterward, autologous Accelerated Growth Factor (AGF) was injected (0.2-0.3 mL per site) into the treated mucosa. AGF was prepared from 10 mL of venous blood using a single-step centrifugation protocol to isolate the growth factor-rich fraction. Gingival thickness and soft tissue parameters were assessed using an intraoral scanner combined with a transgingival file measurement technique at baseline, 3 months, and 6 months.
Accelerated Growth Factor (AGF) Injection OnlyProcedure or surgery
Participants in this arm received autologous Accelerated Growth Factor (AGF) injection alone into the peri-implant mucosa (0.2-0.3 mL per site) in the maxillary anterior region, without prior microneedling. The AGF was prepared from 10 mL of venous blood via a standardized single-step centrifugation procedure to obtain a growth factor-rich fraction. Gingival thickness and soft tissue parameters were evaluated using the same intraoral scanner and transgingival file method at baseline, 3 months, and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Growth Factor (AGF) Injection Only | Active comparator | Participants in this arm received autologous Accelerated Growth Factor (AGF) injection alone into the peri-implant mucosa (0.2-0.3 mL per site) in the maxillary anterior region, without prior microneedling. The AGF was prepared from 10 mL of venous blood via a standardized single-step centrifugation procedure to obtain a growth factor-rich fraction. Gingival thickness and soft tissue parameters were evaluated using the same intraoral scanner and transgingival file method at baseline, 3 months, and 6 months Receives: Procedure: Accelerated Growth Factor (AGF) Injection Only |
| Microneedling Combined with Accelerated Growth Factor (AGF) | Experimental | Participants in this arm received microneedling around the peri-implant mucosa in the maxillary anterior region using sterile disposable glucometer lancets under aseptic conditions. Repeated micro-perforations were created circumferentially until pinpoint bleeding appeared. Immediately afterward, autologous Accelerated Growth Factor (AGF) was injected (0.2-0.3 mL per site) into the treated mucosa. AGF was prepared from 10 mL of venous blood using a single-step centrifugation protocol to isolate the growth factor-rich fraction. Gingival thickness and soft tissue parameters were assessed using an intraoral scanner combined with a transgingival file measurement technique at baseline, 3 months, and 6 months. Receives: Procedure: Microneedling Combined with Accelerated Growth Factor (AGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness (GT)
Gingival thickness will be measured to assess the effect of accelerated growth factor injection with and without microneedling on peri-implant soft tissue phenotype.
Measurements will be taken at the mid-facial point of the implant site using a transgingival file technique combined with digital evaluation via intraoral scanning to ensure accuracy and reproducibility.
Measured: Baseline, 3 months, and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start5 Oct 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion5 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel treatment groups: AGF alone. Microneedling combined with Accelerated Growth Factor (AGF) Each participant receives only one type of intervention, and the outcomes are compared between groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Al-Ahmady El-Meligy, Tanta University
- Investigators
- Doaa M Elgendy, lecturer, Study chair, Lecturer of prosthodontics, faculty of dentistry, Tanta university, Egypt.Shimaa M Eltantawy, lecturer, Principal investigator, Lecturer of fixed prosthodontics, Faculty of Dentistry, Tanta University, EgyptAhmed A Mosleh, lecturer, Study director, Lecturer of oral and maxillofacial surgery, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294287
- Sponsor's protocol ID
- #R-FP-10-24-3150
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bawankar PV, Tuli P, Kolte AP, Kolte RA. Evaluation of the efficacy of microneedling alone and in combination with injectable hyaluronic acid in augmentation of peri-implant soft tissues: A randomized controlled trial. J Indian Soc Periodontol. 2024 Nov-Dec;28(6):643-650. doi: 10.4103/jisp.jisp_158_24. Epub 2025 Apr 3.
PubMed 40313337Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
PubMed 31912532
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Microneedling on the Gingival Tissue Surrounding Implant Supported Fixed Restoration.
- ClinicalTrials.gov ID
- NCT07294287
- Acronym / sponsor ID
- #R-FP-10-24-3150
- Conditions
- Gingiva, Dental Implants
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 5 Jan 2026 (estimated)
- First posted
- 19 Dec 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 randomized clinical trial aims to evaluate the effect of microneedling with and without accelerated growth factor (AGF) injection on gingival tissue surrounding implant-supported fixed restorations. The peri-implant soft tissue phenotype is an important determinant of long-term implant stability and esthetic success. Patients with thin gingival biotype are more susceptible to mucosal recession, soft tissue transparency, and peri-implant complications. Enhancing gingival thickness and keratinized tissue width using minimally invasive methods can improve esthetic and biological outcomes.
Microneedling has recently been proposed as a simple and minimally invasive approach that stimulates local healing by inducing controlled micro-injury. It triggers angiogenesis and the release of intrinsic growth factors that promote soft tissue regeneration. Accelerated Growth Factor (AGF) is an autologous platelet concentrate obtained through a single-step centrifugation technique. It contains a high concentration of platelet-derived and vascular growth factors that enhance tissue repair and collagen synthesis. Combining microneedling with AGF may therefore produce synergistic effects, improving the soft tissue phenotype and peri-implant mucosal stability.
The study will include 20 participants aged 18-34 years with thin gingival biotype (0.8-1 mm) around maxillary anterior implants. Participants will be randomly assigned to one of two groups:
- AGF group: AGF injection alone.
- Microneedling + AGF group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, followed by AGF injection (0.2-0.3 mL per site).
Clinical parameters including gingival thickness (GT), keratinized tissue width (KTW), probing depth (PD), and bleeding index (BI) will be recorded at baseline, 3 months, and 6 months. All participants will receive standardized zirconia restorations following osseointegration. Statistical analysis will include intra- and inter-group comparisons, with significance set at p < 0.05.
The study is expected to clarify whether combining microneedling with AGF enhances peri-implant soft tissue thickness more effectively than AGF alone. If successful, this combined minimally invasive approach may offer a practical and biologically based technique to improve soft tissue health and esthetics around dental implants.
Detailed description
The peri-implant mucosa plays a crucial role in the biological and esthetic stability of dental implants. A thin gingival biotype is often associated with soft tissue recession, marginal bone loss, and esthetic compromise. Conventional augmentation techniques such as connective tissue grafting are effective but involve additional morbidity, donor site discomfort, and variable esthetic results. This study investigates a minimally invasive approach combining microneedling and accelerated growth factor (AGF) injection to enhance the gingival tissue phenotype around implant-supported restorations.
Microneedling is based on creating controlled micro-perforations in the soft tissue surface using fine needles. These micro-injuries induce a natural wound healing cascade that includes platelet activation, release of endogenous growth factors, angiogenesis, and fibroblast stimulation. The process enhances collagen deposition and epithelial thickening, which may increase the overall gingival thickness and keratinized tissue width.
AGF is an autologous blood-derived product obtained by a standardized single-step centrifugation technique that separates platelet-rich fractions containing high levels of biologically active molecules such as PDGF, VEGF, and TGF-β. These factors promote tissue regeneration and accelerate wound healing. Injecting AGF into peri-implant mucosa provides a reservoir of growth factors that stimulate fibroblast activity, improve tissue vascularity, and enhance collagen formation.
The hypothesis of this trial is that combining microneedling with AGF will yield superior soft tissue enhancement compared to AGF alone.
Study Design
This is a prospective, randomized, single-blinded, parallel-arm interventional clinical trial. 20 sites for patients aged 18-34 years with thin gingival biotype (0.8-1mm) in the maxillary anterior region will be included. Participants will be randomly assigned to two groups using a computer-generated random sequence:
- AGF Group: AGF injection only.
- Microneedling + AGF Group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, immediately followed by AGF injection (0.2-0.3 mL per site).
Methodology
The study follows five sequential phases:
- Pre-surgical Phase: Clinical and radiographic evaluation, oral hygiene instructions, baseline measurement of GT, KTW, PD, and BI.
- Surgical Phase: Implant placement in the maxillary anterior region followed by 3-4 months of osseointegration.
- Intervention Phase: Randomized treatment application after healing.
- Restorative Phase: Fabrication and cementation of standardized zirconia crowns.
- Follow-up Phase: Assessment of all parameters at baseline, 3, and 6 months. Outcome Measures
- Primary Outcome: Gingival thickness (GT) at baseline, 3, and 6 months.
- Secondary Outcomes: Keratinized tissue width (KTW), probing depth (PD), and bleeding index (BI).
Statistical Analysis Data will be analyzed using SPSS software (IBM). Paired and unpaired t-tests will compare intra- and inter-group differences. The significance level will be set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel treatment groups: AGF alone. Microneedling combined with Accelerated Growth Factor (AGF) Each participant receives only one type of intervention, and the outcomes are compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Accelerated Growth Factor (AGF) Injection Only | Active comparator | Procedure: Accelerated Growth Factor (AGF) Injection OnlyParticipants in this arm received autologous Accelerated Growth Factor (AGF) injection alone into the peri-implant mucosa (0.2-0.3 mL per site) in the maxillary anterior region, without prior microneedling. The AGF was prepared from 10 mL of venous blood via a standardized single-step centrifugation procedure to obtain a growth factor-rich fraction. Gingival thickness and soft tissue parameters were evaluated using the same intraoral scanner and transgingival file method at baseline, 3 months, and 6 months |
| Microneedling Combined with Accelerated Growth Factor (AGF) | Experimental | Procedure: Microneedling Combined with Accelerated Growth Factor (AGF)Participants in this arm received microneedling around the peri-implant mucosa in the maxillary anterior region using sterile disposable glucometer lancets under aseptic conditions. Repeated micro-perforations were created circumferentially until pinpoint bleeding appeared. Immediately afterward, autologous Accelerated Growth Factor (AGF) was injected (0.2-0.3 mL per site) into the treated mucosa. AGF was prepared from 10 mL of venous blood using a single-step centrifugation protocol to isolate the growth factor-rich fraction. Gingival thickness and soft tissue parameters were assessed using an intraoral scanner combined with a transgingival file measurement technique at baseline, 3 months, and 6 months. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-34 years
- Thin gingival biotype ( 0.8- 1mm GT at maxillary anterior teeth)
- Non-smokers
- Plaque index (PI) score 0-1
- No bleeding on probing
Key exclusion criteria (5 listed)
- Active orthodontic treatment
- Previous periodontal surgery at study sites
- Systemic diseases affecting healing
- Use of anticoagulants or drugs causing gingival enlargement
- Mucogingival stress or bruxism
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 |
|---|---|---|
| Microneedling Combined with Accelerated Growth Factor (AGF)Participants in this arm received microneedling around the peri-implant mucosa in the maxillary anterior region using sterile disposable glucometer lancets under aseptic conditions. Repeated micro-perforations were created circumferentially until pinpoint bleeding appeared. Immediately afterward, autologous Accelerated Growth Factor (AGF) was injected (0.2-0.3 mL per site) into the treated mucosa. AGF was prepared from 10 mL of venous blood using a single-step centrifugation protocol to isolate the growth factor-rich fraction. Gingival thickness and soft tissue parameters were assessed using an intraoral scanner combined with a transgingival file measurement technique at baseline, 3 months, and 6 months. | Procedure or surgery | Microneedling Combined with Accelerated Growth Factor (AGF) |
| Accelerated Growth Factor (AGF) Injection OnlyParticipants in this arm received autologous Accelerated Growth Factor (AGF) injection alone into the peri-implant mucosa (0.2-0.3 mL per site) in the maxillary anterior region, without prior microneedling. The AGF was prepared from 10 mL of venous blood via a standardized single-step centrifugation procedure to obtain a growth factor-rich fraction. Gingival thickness and soft tissue parameters were evaluated using the same intraoral scanner and transgingival file method at baseline, 3 months, and 6 months | Procedure or surgery | Accelerated Growth Factor (AGF) Injection Only |
Primary outcome
Gingival thickness (GT)
Time frame: Baseline, 3 months, and 6 months after intervention
Gingival thickness will be measured to assess the effect of accelerated growth factor injection with and without microneedling on peri-implant soft tissue phenotype. Measurements will be taken at the mid-facial point of the implant site using a transgingival file technique combined with digital evaluation via intraoral scanning to ensure accuracy and reproducibility.
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 19 Dec 2025.
- Background: PubMed 40313337Bawankar PV, Tuli P, Kolte AP, Kolte RA. Evaluation of the efficacy of microneedling alone and in combination with injectable hyaluronic acid in augmentation of peri-implant soft tissues: A randomized controlled trial. J Indian Soc Periodontol. 2024 Nov-Dec;28(6):643-650. doi: 10.4103/jisp.jisp_158_24. Epub 2025 Apr 3.
- Background: PubMed 31912532Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Doaa M Elgendy, lecturer study chair
Lecturer of prosthodontics, faculty of dentistry, Tanta university, Egypt.
Shimaa M Eltantawy, lecturer principal investigator
Lecturer of fixed prosthodontics, Faculty of Dentistry, Tanta University, Egypt
Ahmed A Mosleh, lecturer study director
Lecturer of oral and maxillofacial surgery, Faculty of Dentistry, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling Combined with Accelerated Growth Factor (AGF) and Accelerated Growth Factor (AGF) Injection Only in people with Gingiva and Dental Implants, run by Tanta University at 1 site in Egypt.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival thickness (GT) (time frame: Baseline, 3 months, and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07294287, which also lists 2 linked publications.
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 19 Dec 2025.