Volumetric Analysis of Recipient and Donor Sites Following Free Gingival Graft Surgery Harvested From Different Palatal Donor Sites: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Volumetric change at the recipient site
研究概览
简要总结
This randomized controlled clinical trial evaluated volumetric changes at recipient and donor sites following free gingival graft (FGG) surgery, comparing two different palatal donor regions. Forty systemically healthy non-smoking adults aged 20-40 years with Miller Class I gingival recession defects at the mandibular anterior teeth (teeth 31, 32, 41, and 42) were randomly allocated using a sealed envelope method into two groups based on the donor site: (1) the anterior palatal region (from the distal of the canine to the first molar), and (2) the posterior palatal/tuberosity region (between the first molar and the tuberosity). All grafts were harvested targeting a standardized size of 8x10 mm (80 mm²). Digital intraoral scans (3Shape TRIOS 5) were obtained preoperatively and at 1, 3, and 6 months postoperatively. Volumetric changes at both recipient and donor sites were measured using STL-based superimposition in Exocad software. The aim was to compare time-dependent volumetric change patterns at both the recipient and donor sites between the two donor groups.
详细描述
BACKGROUND:
Free gingival graft (FGG) is a well-established procedure to augment keratinized tissue width and manage gingival recession defects. Despite widespread clinical use, comparative data on volumetric outcomes from different palatal donor sites remain limited, and most existing studies rely on one-dimensional clinical measurements rather than volumetric analysis. Emerging evidence suggests that donor tissue composition may differ between anterior palatal and posterior palatal/tuberosity regions, potentially influencing graft behavior at the recipient site.
STUDY DESIGN:
Single-center, parallel-group, randomized controlled clinical trial with 1:1 allocation via sealed envelope randomization.
INTERVENTION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 20 to 40 years (both male and female)
- •Presence of Miller Class I gingival recession at mandibular anterior teeth (teeth 31, 32, 41, and 42)
- •Systemically healthy (no known systemic diseases)
- •Non-smokers
- •Adequate oral hygiene
- •Able and willing to provide written informed consent and attend follow-up visits
排除标准
- •Pregnancy or lactation
- •Current or past smoking
- •Diagnosis of diabetes mellitus
- •Use of isotretinoin or similar systemic anti-acne medications
- •Inadequate oral hygiene
- •Current anticoagulant therapy
- •Systemic contraindications to periodontal surgery
- •History of previous periodontal surgery at the recipient site
研究组 & 干预措施
Anterior Palatal Donor Group
Free gingival graft was harvested from the anterior palatal region, defined as the area between the distal of the maxillary canine and the first molar. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures.
干预措施: Free Gingival Graft from Anterior Palatal Donor Site (Procedure)
Posterior Palatal / Tuberosity Donor Group
Free gingival graft was harvested exclusively from the maxillary tuberosity region. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures.
干预措施: Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site (Procedure)
结局指标
主要结局
Volumetric change at the recipient site
时间窗: 1, 3, and 6 months postoperatively
Standardized volumetric change (mm³) at the recipient site compared with preoperative baseline (T0), measured via three-dimensional STL-based superimposition of intraoral scans (3Shape TRIOS 5) using Exocad software. Volumetric data were mathematically normalized to a theoretical standard graft surface area of 80 mm² (8x10 mm) to account for minor graft size variations. Negative values indicate volume loss; positive values indicate volume gain relative to baseline.
次要结局
- Volumetric change at the donor site(1, 3, and 6 months postoperatively)
- Time × donor-site interaction effect on volumetric change at the recipient site(Across 1, 3, and 6 months postoperatively)
研究者
Hooman Hashemzadeh
Sub-Investigator, Department of Periodontology
Ondokuz Mayıs University