Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201505001096342 Date of Approval: 07/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating lip repositioning technique with and without myotomy for the treatment of excess gingival display:randomized clinical trial
Official scientific title Evaluating lip repositioning technique with and without myotomy for the treatment of excess gingival display:randomized clinical trial
Brief summary describing the background and objectives of the trial In adult patients with excess gingival display, will surgical lip repositioning compared to surgical lip repositioning with myotomy differ in esthetic outcome, gingival display, postoperative complications and postoperative morbidity as well as stability of the achieved result?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Gummy smile,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2015
Actual trial start date
Anticipated date of last follow up 05/04/2015
Actual Last follow-up date 05/03/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computer randomization sequence generation using random.org Each patient will be allocated a number fom sequentially numbered opaque sealed envelopes when they were seen for consent and initial record. They will be allocated into one of the set ups using a randomization table. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lip repositioning A single-two line- elliptical incision is created in the depth of the vestibule 20
Experimental Group Lip repositioning Single partial thickness elliptical incision extending from upper left first molar to upper right first molar 20
Experimental Group Lip repositioning A single- two line- elliptical incision is created in the depth of the vestibule, with muscle severance 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
2 mm gingival display Patient under 40 years Upper anteriors must be natural dentition Good oral hygiene Motivated Heavy smokers Uncontrolled diabete Inadequate amount of attached gingiva Periodontitis/gingival recession 13 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/11/2014 Ethics committee- Cairo Univeristy
Ethics Committee Address
Street address City Postal code Country
12 Saray Al-Manial st. Al-Kasr Al Einy Cairo 22311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reducing exces gum display 2 weeks post surgical 3 months post surgical 6 months post surgical
Secondary Outcome Patient satisfaction 6 months
Secondary Outcome Postoperative morbidity (pain) 1 week 2 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral and Dental medicine-Cairo University 12 Saray al Manial st. Al Kasr Al-Einy Cairo 12311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Oral and Dental Medicine- Cairo Univeristy 12 Saray Al-Manial st. Al Kasr Al Einy Cairo 12311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine- Cairo University 12 Saray Al-Manial street. Al Kasr Al Einy Cairo 12311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Omnia Tawfik 12 Saray Al Manial street. Kasr Al Einy Cairo 12311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omnia Tawfik Ok.tawfik@gmail.com 01006002618 12 Saray Al Manial st. Al Kasr Al Einy
City Postal code Country Position/Affiliation
Cairo 12311 Egypt Assistant lecturer/ principal investigator
Role Name Email Phone Street address
Public Enquiries Omnia Tawfik Ok.tawfik@gmail.com 01006002618 12 Saray Al Manial street, Al Kasr Al Ainy
City Postal code Country Position/Affiliation
Cairo 12311 Egypt
Role Name Email Phone Street address
Scientific Enquiries Omnia Tawfik Ok.tawfik@gmail.com 01006002618 12Saray Al Manial street, Al Kasr Al Ainy,
City Postal code Country Position/Affiliation
Cairo 12311 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information