Gingival Overgrowth
Conditions
Keywords
Crown Lengthening, Digital Surgical Guide, Guided Surgery
Brief summary
This randomized controlled clinical trial aims to evaluate the clinical performance and patient-centered outcomes of dual digitally guided crown lengthening compared to the conventional surgical technique in the management of gummy smile caused by altered passive eruption (Type B1). A total of 18 patients will be randomly allocated into two groups: the control group will undergo conventional crown lengthening based on clinical measurements, while the intervention group will receive crown lengthening using a dual digitally fabricated surgical guide. The primary outcome is the gain in clinical crown length at 3 months. Secondary outcomes include operating time, pain perception, patient satisfaction, gingival margin stability, and periodontal clinical parameters. This study aims to determine whether digital guidance improves surgical accuracy, efficiency, and patient satisfaction compared to traditional techniques
Detailed description
Esthetic crown lengthening is a commonly performed periodontal surgical procedure indicated for the correction of excessive gingival display, particularly in cases of altered passive eruption. Achieving optimal esthetic outcomes requires precise determination of gingival and osseous resection levels, which can be challenging using conventional clinical methods. With the advancement of digital dentistry, computer-aided design and manufacturing (CAD/CAM) technologies have enabled the development of digitally guided surgical approaches. The dual digitally guided technique integrates two levels of guidance to control both soft tissue and bone resection, potentially enhancing surgical precision and predictability. This randomized controlled clinical trial is designed to compare the effectiveness of dual digitally guided crown lengthening with the conventional technique in patients presenting with gummy smile due to altered passive eruption (Type B1). Eighteen systemically healthy patients aged 18-40 years will be recruited and randomly assigned into two equal groups. The control group will undergo conventional crown lengthening using clinical measurements and manual surgical techniques. The intervention group will be treated using a dual digitally fabricated surgical guide based on digital smile design, CBCT analysis, and intraoral scanning. Clinical and patient-reported outcomes will be assessed at baseline and during follow-up periods. The primary outcome is the gain in clinical crown length measured at 3 months postoperatively. Secondary outcomes include operating time, pain (VAS), patient satisfaction (VAS), gingival margin level, probing depth, gingival index, plaque index, bleeding on probing, keratinized gingival height, and gingival thickness. The results of this study are expected to provide evidence regarding the benefits of digital guidance in periodontal esthetic surgery and its potential to improve clinical outcomes and patient experience.
Interventions
PROCEDUREConventional Crown Lengthening
Conventional surgical crown lengthening performed based on clinical examination and manual measurements. The procedure includes gingival recontouring and osseous resection carried out according to standard periodontal surgical protocols without the use of digital guidance.
PROCEDUREDual Digitally Guided Crown Lengthening
Crown lengthening performed using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT imaging to guide both soft tissue and bone resection, enhancing surgical accuracy and predictability.
Sponsors
Arab International University
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting with gummy smile due to altered passive eruption (Type B1) * Presence of at least 6 maxillary anterior teeth indicated for crown lengthening * Good oral hygiene and ability to maintain plaque control * Systemically healthy patients
Exclusion criteria
* Poor oral hygiene * Smokers * Pregnancy or lactation * Systemic diseases affecting periodontal tissues * Previous periodontal surgery in the study area * Active periodontal disease * Presence of periapical pathology in the study area * Ongoing orthodontic treatment * Gummy smile due to skeletal or muscular causes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gain in Clinical Crown Length | Baseline and 3 months postoperatively | Change in clinical crown length (mm), measured from the incisal edge to the gingival margin using a periodontal probe, to assess the effectiveness of crown lengthening procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Thickness | Baseline and 3 months postoperatively | Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods. |
| Bleeding on Probing (BOP) | Baseline and 3 months postoperatively | Presence or absence of bleeding upon gentle probing, expressed as a percentage of bleeding sites. |
| Surgical Operating Time | During surgery (intraoperative) | Total duration of the surgical procedure measured in minutes from the first incision to completion of osteotomy. |
| Postoperative Pain (Visual Analog Scale) | 24 hours, 7 days, and 14 days postoperatively | Patient-reported pain assessed using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). |
| Patient Satisfaction (Visual Analog Scale) | 7 days and 3 months postoperatively | Patient satisfaction with the esthetic and functional outcome measured using a Visual Analogue Scale (VAS). |
| Relative Gingival Margin Level | Baseline, 1 week, and 3 months postoperatively | Measurement of gingival margin position (mm) relative to a fixed reference point to evaluate soft tissue stability. |
| Probing Depth | Baseline and 3 months postoperatively | Periodontal probing depth (mm) measured at standardized sites using a periodontal probe. |
| Gingival Index (GI) | Baseline and 3 months postoperatively | Assessment of gingival inflammation using the Gingival Index scoring system. |
| Keratinized Gingival Height | Baseline, 1 week, and 3 months postoperatively | Width of keratinized gingiva (mm) measured from the gingival margin to the mucogingival junction. |
| Plaque Index (PI) | Baseline and 3 months postoperatively | Assessment of oral hygiene status using the Plaque Index scoring system. |
Countries
Syria
Contacts
PRINCIPAL_INVESTIGATORRaghad Alrefaai, DDs
Damascus University
STUDY_CHAIRRazan Khattab, PhD
Damascus University
STUDY_DIRECTORSaleh Al Kurdi, PhD
Arab International University
Outcome results
None listed