Impact of Microneedling on the Gingival Tissue Surrounding Implant Supported Fixed Restoration.

NCT ID: NCT07294287

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-05
• Study Completion Date: 2026-01-05

Brief 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. 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:

1. AGF group: AGF injection alone.

2. 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:

1. AGF Group: AGF injection only.

2. 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:

1. Pre-surgical Phase: Clinical and radiographic evaluation, oral hygiene instructions, baseline measurement of GT, KTW, PD, and BI.

2. Surgical Phase: Implant placement in the maxillary anterior region followed by 3-4 months of osseointegration.

3. Intervention Phase: Randomized treatment application after healing.

4. Restorative Phase: Fabrication and cementation of standardized zirconia crowns.

5. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Accelerated Growth Factor (AGF) Injection Only

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

Group Type: ACTIVE_COMPARATOR

Accelerated Growth Factor (AGF) Injection Only

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Microneedling Combined with Accelerated Growth Factor (AGF)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Accelerated Growth Factor (AGF) Injection Only

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mona Al-Ahmady El-Meligy

Lecturer of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Faculty of Dentistry, Tanta University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doaa M Elgendy, lecturer

Role: STUDY_CHAIR

Lecturer of prosthodontics, faculty of dentistry, Tanta university, Egypt.

Shimaa M Eltantawy, lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer of fixed prosthodontics, Faculty of Dentistry, Tanta University, Egypt

Ahmed A Mosleh, lecturer

Role: STUDY_DIRECTOR

Lecturer of oral and maxillofacial surgery, Faculty of Dentistry, Tanta University, Egypt

Locations

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

References

Toita T. [Uterine cervical cancer]. Nihon Igaku Hoshasen Gakkai Zasshi. 2002 Apr;62(5):198-201. Japanese.

Reference Type: BACKGROUND

PMID: 12043223 (View on PubMed)

Ozsagir 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.

Reference Type: BACKGROUND

PMID: 31912532 (View on PubMed)

Other Identifiers

#R-FP-10-24-3150

Identifier Type: -

Identifier Source: org_study_id