Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile (A Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Gingival display
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
VISTA and Milled PEEK stent
Intervention: Milled PEEK Stent (Other)
Lip repositioning surgery
Intervention: Lip repositioning surgery (Procedure)
Outcomes
Primary Outcomes
Gingival display
Time Frame: up to 9 months
Distance from gingival margin to lower border of upper lip vermilion border will be measured
Facial Edema (Swelling)
Time Frame: 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.
Postoperative pain assessment
Time Frame: 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
Healing Quality
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
taher helmy ismail metwaly
MSc. Candidate in Periodontology
Alexandria University