Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile

Not Applicable

Completed

• Conditions: Gummy Smile

• Registration Number: NCT06983262
• Lead Sponsor: taher helmy ismail metwaly

Brief Summary

The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-14
• Study First Submitted: 2025-03-04
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-10
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Systemically healthy individuals
• Chiefs complain gummy smile
• Gummy smile due to short hypermobile upper lip
• Gingival Display not more than 5 mm

Exclusion Criteria

• Pregnancy
• Lactation
• History of smoking more than 10 cigarettes per day
• Systemic conditions or intake of medications that could affect soft and hard tissue healing
• Use of orthodontic appliances
• Gingival display above 5mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain assessment	up to one week	Postoperative pain will be evaluated at first and seventh day using numeric rating scale (NRS). Patient will rate his pain on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.; * 0 = no pain; * 1-3 = mild pain; * 4-6 = moderate pain; * 7-10 = severe pain
Facial Edema (Swelling)	up to one week	Postoperative edema was measured with a flexible tape measure by calculating the distance between several facial landmarks and comparing them to preoperative values.
Gingival display	up to 6 months	Distance from gingival margin to lower border of upper lip vermilion border will be measured
Healing Quality	up to 3 weeks	Measured according to Landry's Healing Index which records healing on basis of tissue colour, bleeding, ulceration, granulation tissue and epithelisation.; Scores range from 1 (Very poor) to 5 (excellent)

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt