An interventional study of Stackable double digital periodontal guide and Conventional double digital periodontal guide in Gummy Smile of Altered Passive Eruption Type 1B, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to find out if a new digital surgical guide helps dentists perform esthetic crown lengthening more accurately than the current digital guide in adults with a gummy smile caused by altered passive eruption. Esthetic crown lengthening is a procedure that reshapes the gums and the bone around the teeth to show more of the natural tooth. The main questions this study aims to answer are:
Does the new digital guide help dentists reshape the bone and gums more accurately? Does the new digital guide improve healing, the appearance of the gums, the time needed for surgery, and participants' satisfaction with the results?
Researchers will compare a new stackable digital guide with the current digital guide to see if the new design provides more accurate and predictable results.
Participants will:
Esthetic crown lengthening is a surgical procedure used to improve the appearance of a "gummy smile" by exposing more of the natural tooth. One common cause of a gummy smile is altered passive eruption, a condition in which the gums cover more of the teeth than normal, making the teeth appear shorter. In some patients, treatment requires not only reshaping the gums but also removing a small amount of the supporting bone to create a healthy and stable relationship between the teeth, gums, and bone.
Digital technology has improved treatment planning for esthetic crown lengthening by allowing surgical guides to be designed using intraoral scans and cone-beam computed tomography (CBCT) images. These guides help the surgeon identify the planned gum and bone levels during surgery. However, currently available double digital periodontal guides may become less stable after the gum tissue is lifted during surgery because the guide is positioned on the soft tissue rather than directly on the bone. This may reduce the accuracy of bone reshaping.
This study will evaluate a newly designed stackable double digital periodontal guide that consists of two separate components. The first component is used to guide the gum incision, while the second component is attached after the gum flap is reflected and rests directly on the bone to guide bone reduction. This design is intended to improve guide stability during surgery and increase the accuracy of bone reshaping. The new guide will be compared with a conventional one-piece double digital periodontal guide.
Thirty adults with altered passive eruption type 1B who require esthetic crown lengthening will be enrolled and randomly assigned to one of the two treatment groups. All participants will receive the same standard preoperative assessment, including clinical examination, digital photographs, intraoral scanning, CBCT imaging, oral hygiene instructions, and nonsurgical periodontal therapy before surgery. Both groups will undergo esthetic crown lengthening using their assigned digital guide according to standardized surgical procedures.
Participants will be evaluated immediately after surgery and during follow-up visits at 6 weeks and 6 months. Digital intraoral scans and CBCT images will be used to compare the planned treatment with the actual surgical outcome. Additional assessments will include the stability of the gum margin, esthetic appearance of the gums, duration of surgery, postoperative pain medication use, and participant satisfaction with the treatment.
The findings of this study will provide evidence on whether the stackable digital guide offers improved surgical accuracy and more predictable clinical outcomes compared with the conventional digital guide. This information may help optimize digital workflows for esthetic crown lengthening and improve treatment planning for patients requiring correction of excessive gingival display.
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants undergo esthetic crown lengthening using a stackable double digital periodontal guide. The guide consists of separate gingivectomy and ostectomy components that are assembled during surgery to guide bone reduction.
Device: Stackable double digital periodontal guide
Participants undergo esthetic crown lengthening using a conventional one-piece double digital periodontal guide
Device: Conventional double digital periodontal guide
A custom-made, 3D-printed digital surgical guide used during esthetic crown lengthening. The guide consists of two detachable components: a gingivectomy guide for soft tissue incision and an ostectomy guide that is joined after flap reflection and positioned directly on the alveolar bone to guide bone reduction. The guide is designed using merged cone-beam computed tomography (CBCT) and intraoral scan data to improve the accuracy of bone reshaping.
A custom-made, one-piece 3D-printed digital surgical guide used during esthetic crown lengthening. The guide directs both the gingivectomy and ostectomy based on the planned treatment using intraoral scan data . After flap reflection, the guide is repositioned to guide bone reduction from the soft tissue level.
Also known as: double periodontal guide, digital periodontal guide, dual periodontal guide, dual digital periodontal guide
Difference in accuracy of both guides
Evaluation of the degree of matching of the post operative actual gingival zenith points with the virtual predicted presurgical plan. Intraoral digital scanning for both groups will be obtained preoperative, immediately after surgery, and follow up appointments at 6 weeks and 6 months after surgery and exported in STL file format then it will be superimposed on the digitally designed diagnostic STL file to obtain statistical differences.The accuracy can be measured by comparing the planned surgery and the actual result of the surgery Linear measurement in millimeters.
Time frame: 6 months
Bone level accuracy
The accuracy can be measured by comparing the planned surgical ostectomy level on the CBCT (cone beam computed tomography) and the actual result of the surgery by Linear measurement in millimeters.
Time frame: 6 months
Gingival margin stability
The position of gingival margin in relation to a reference point will be evaluated with linear measurements in millimeters.
Time frame: 6 Months
Pink Esthetic Score
The \*\*Pink Esthetic Score evaluates seven variables of soft-tissue esthetics. 1)Mesial and distal papillae are scored as missing (0), incomplete (1), or complete (2). 2)Tissue contour is rated as unnatural (0), virtually natural (1), or natural (2). 3)Gingival level is scored according to the discrepancy from the reference tooth: \>2 mm (0), 1-2 mm (1), or \<1 mm (2). 4)Alveolar process, color, and texture are each scored (0),(1) and (2), depending on whether there is a (0)clear difference, (1)slight difference, or (2)no difference. Higher scores indicate better esthetic outcomes with a maximum total score of 14.
Time frame: 6 months
Surgical time
The time needed to complete each procedure will be calculated in minutes by using a stopwatch from the time of the first incision till removal of the guide.
Time frame: time of the surgery
Patient satisfaction
Patient satisfaction was assessed using three direct questions previously applied in Kiyak et al.14: * "Considering this was an elective operation, how likely would you be to recommend it to others?". * "If you had to make the decision again, how likely would you be to undergo this surgery?". * "Considering everything, how satisfied are you with the outcomes of your surgery?". Responses were recorded using a seven-point Likert scale ranging from 1 (not at all likely or not satisfied) to 7 (very likely or very satisfied).
Time frame: 2 weeks
analgesics
number of analgesics the patient took after the surgery till the day of sutures removal
Time frame: 2 weeks
No study locations are listed for this record.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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