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.: PACTR202007628100458 Date of Approval: 13/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Photodynamic versus diode laser on the treatment of localized aggressive periodontitis
Official scientific title Effect of photodynamic therapy versus diode laser therapy on the treatment of localized aggressive periodontitis.
Brief summary describing the background and objectives of the trial Localized aggressive periodontitis(LAP) is a severe form of periodontal disease, that affects younger people, so it is a challenging disease, that needs rapid intervention. There are numerous treatment strategies including scaling and root planing (SRP), antibiotics, local drug delivery and surgical techniques for treatment of LAP. Nevertheless, they are associated with certain limitations. To overcome the limitations, antimicrobial photodynamic therapy (PDT) has been proposed as a treatment strategy for periodontal disease. The benefits of PDT include instant suppression of causative periopathogenic bacteria, minimum antibiotic resistance, absence of systemic disturbance and undesirable effects on the healthy periodontal tissue. The aim of the present study is to evaluate the effect of diode laser alone versus PDT using indocyanine green in repeated form as adjunct to scaling and root planing on management of localized aggressive periodontitis clinically, immunologically and microbiologically.
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: Drugs
Anticipated trial start date 16/11/2017
Actual trial start date 16/11/2017
Anticipated date of last follow up 16/03/2019
Actual Last follow-up date 16/03/2019
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Completed
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Photodynamic therapy at baseline 7 days and 21 days Make full mouth scaling an root planning and then apply dye in the pocket till it flood and then apply fiber inside the pocket to activate and initiate the photosensitizer But in laser group apply laser fiber after scaling to debride the pocket and granulation tissue and at the end of each group induce blood by a periodontal probe and pack pocket with collagen sponge to induce angiogenesis and apply the periodontal pack. 15
Experimental Group Laser therapy at baseline 7 days and 21 days Step A: Trans-gingival irradiation was performed by bleaching handpiece non-contact continuous mode for 10 seconds. Step B: All pockets were irradiated by a 300 um bulb fiber in a circular pattern for 15 seconds in non- contact continuous mode. Step C: Granulation tissue was removed from the infected pockets using a300um bare fiber in a circular pattern for 40 seconds using continuous contact mode. 15
Control Group Scaling and root planning at baseline Scaling and root planning followed by collagen sponge packing the pocket 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with localized aggressive periodontitis. The patient must be medically free. Optimal compliance as evidenced by no missed treatment appointment and positive attitude for maintain oral hygiene. Patients who are willing to be enrolled in this study and has the ability to complete the study. Pregnancy Patients receiving antibiotic therapy or scaling and root planning in the last six months. Hypersensitivity toward photosensitizer. Adult: 19 Year-44 Year 18 Year(s) 35 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 28/02/2017 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31773 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome probing pocket depth Baseline, 3 months, 6 months
Primary Outcome Clinical attachment level Baseline, 3 months, 6 months
Primary Outcome Rt-PCR for (Aggregatibacter Actinomycetecomitans) Baseline, 3 months, 6 months
Secondary Outcome ElISA for MMP-8 inflammatory cytokine. Baseline, 3 months, 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinical of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Mohammed Ahmed Sagha El Gash street Medical Campus Tanta 31773 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Mohammed Nassar El Gash street Medical Campus Tanta 31773 Egypt
Malak Yousef shoukheba El Gash street Medical Campus Tanta 31773 Egypt
Marwa Mohamed Ezzat El Gash street Medical Campus Tanta 31773 Egypt
Sara Mohammed Ahmed Sagha El Gash street Medical Campus Tanta 31773 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Nassar Prof_nassar1949@yahoo.co 00201121522221 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Malak Shoukheba malak.mohamed@dent.tanta.edu.eg 00201210555478 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Assistant Professor of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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