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.: PACTR202307891237031 Date of Approval: 17/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Free Buccal Fat Pad Graft with and without Advanced Platelet-Rich Fibrin in the Treatment of Localized Gingival Recession (A Randomized Controlled Clinical Trial)
Official scientific title Evaluation of Free Buccal Fat Pad Graft with and without Advanced Platelet-Rich Fibrin in the Treatment of Localized Gingival Recession (A Randomized Controlled Clinical Trial)
Brief summary describing the background and objectives of the trial Recently, new treatment modalities have been proposed to be replaced in cases of ordinary gingival grafting procedures such as the buccal fat pad (BFP) reported as a pedicelled graft for the treatment of severe gingiva recessions in maxillary molars. As periodontal wound healing is a complex biological process consisting of multiple concurrent cellular events leading to repair or regeneration. With the knowledge of the biological features of the platelet concentrates, the initial protocols evolved from the platelet concentrates of the first generation that include platelet-rich plasma (PRP) and plasma rich in growth factors (PGRF) to the second-generation concentrates. So, we hypothesize that the combination of the free buccal fat graft with advanced platelet-rich fibrin will provide a promising solution as compared to the gold standard connective tissue graft in localized gingival recession treatment in terms of both patient and soft tissue-related outcomes. Objectives; To evaluate the effectiveness of free buccal pad fat graft combined with advanced platelet-rich fibrin in comparison with the following : (1) Free buccal pad graft alone. (2) Advanced platelet-rich fibrin. (3) Connective tissue graft. As all the previously mentioned treatment modalities will use coronally advanced flap in localized gingival recession treatment with the primary outcome of this study will be the percentage of root coverage, whereas the secondary outcomes include recession depth, probing depth, clinical attachment level, width of keratinized gingiva, gingival thickness, visual analogue scale to record post-operative pain, hypersensitivity, and patient satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 01/09/2024
Actual Last follow-up date 01/10/2024
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group gingival recession surgery none 6 months follow up It will include twenty patients and they will be treated with the coronally advanced flap and non-pedicled buccal pad graft combined with advanced platelet-rich fibrin. 20
Experimental Group gingival recession surgery none 6 months follow up It will include twenty patients and they will be treated with the coronally advanced flap and non-pedicled buccal pad graft. 20
Experimental Group gingival recession surgery none 6 months follow up It will include twenty patients and they will be treated with the coronally advanced flap and advanced platelet-rich fibrin. 20
Control Group gingival recession treatment none 6 months follow up It will include twenty patients and they will be treated with the coronally advanced flap and connective tissue graft. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Localized Cairo’s RT1≥2mm (8). (2) All patients are between 18 and 50 years. (3) Non-smokers. (4) Non-pregnant. (5) Systemically healthy. (6) Periodontally healthy with no contraindications for periodontal surgery. (7) No use of any kind of medication that could interfere with the health of gingival or periodontal tissue. (8) Teeth with a probing depth (PD) of <3 mm and without bleeding on probing. (9) Teeth with no caries or restorations in the cervical region. (10) Not undergone any prior periodontal surgery in the relevant regions. (1) Multiple adjacent gingival recessions, and lingual recession in the selected teeth. (2) Systemic chronic conditions are known to be associated with periodontitis or with changes in systemic inflammation. (3) Presence of malocclusion/patients with orthodontic therapy in progress. (4) Previous history of periodontal disease/surgical periodontal therapy. Adult: 19 Year-44 Year 18 Year(s) 50 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 20/06/2023 Research Ethics Committee of the Faculty of Dentistry
Ethics Committee Address
Street address City Postal code Country
algomhoria street Mansoura 35516 Egypt
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 14/06/2023 Mansoura faculty of dentistry ethical committee
Ethics Committee Address
Street address City Postal code Country
algomhoria street mansoura city 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the percentage of root coverage 0,3,6 months
Secondary Outcome recession depth, probing depth, clinical attachment level, width of keratinized gingiva, gingival thickness, visual analoge scale to record post-operative pain, hypersensitivity, and patient satisfaction. 0,3,6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university algomhoria street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none algomhoria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Reham Abdelfatah algomhoria street Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hesham ElSharkawy heshammrs@mans.edu.eg 01015559939 algomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of Oral Medicine and Periodontology
Role Name Email Phone Street address
Public Enquiries Ayman Elkashty draymanelkashty@mans.edu.eg 01002771732 algomhoria street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of oral medicine and periodontology
Role Name Email Phone Street address
Scientific Enquiries Reham Abdelfatah rehammohamed230@mans.edu.eg 01202403013 El galaa street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer assistant of oral medicine and periodontology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the data will be available including Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code after deidentification. The data will be available immediately following publication with no end date for anyone who wishes to access the data. the data will be available indefinitely at (Link to be included) for the research purpose in the scientific committee. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol no end date Link to be included
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information