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

NCT07294287 | Active Not Recruiting DMC

• 1 other identifier: #R-FP-10-24-3150
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.AGF group: AGF injection alone.
2. 2.Microneedling + AGF group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, followed by AGF injection (0.2-0.3 mL per site).

Conditions

Gingiva; Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months, and 6 months after intervention

Study Arms (2)

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

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.

Procedure: Microneedling Combined with Accelerated Growth Factor (AGF)

Interventions

Microneedling Combined with Accelerated Growth Factor (AGF) 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.

Microneedling Combined with Accelerated Growth Factor (AGF)

Accelerated Growth Factor (AGF) Injection Only 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

Accelerated Growth Factor (AGF) Injection Only

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 40313337 BACKGROUND

• 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.

  PMID: 31912532 BACKGROUND

MeSH Terms

Interventions

Angiopoietin-Like Protein 6

Intervention Hierarchy (Ancestors)

Angiopoietin-like Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Doaa M Elgendy, lecturer

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

  STUDY CHAIR

• Shimaa M Eltantawy, lecturer

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

  PRINCIPAL INVESTIGATOR

• Ahmed A Mosleh, lecturer

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Faculty of Dentistry, Tanta University, Egypt

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: October 5, 2024
• Primary Completion: December 10, 2025
• Study Completion: January 5, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)