UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053292 |
|---|---|
| Receipt number | R000060823 |
| Scientific Title | Integrating Low-Level Laser Therapy with Flap Surgery for Intrabony Defects |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2024/01/08 13:57:36 |
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Basic information
Public title
Integrating Low-Level Laser Therapy with Flap Surgery for Intrabony Defects
Acronym
Low-Level Laser Therapy with Flap Surgery for Intrabony Defects
Scientific Title
Integrating Low-Level Laser Therapy with Flap Surgery for Intrabony Defects
Scientific Title:Acronym
Low level laser therapy for Intrabony Defects
Region
| Asia(except Japan) |
Condition
Condition
Intrabony Defects Periodontla disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this randomized controlled trial was to evaluate the effectiveness of Low-Level Laser Therapy (LLLT) as an adjunctive treatment to standard periodontal flap surgery in the management of intrabony periodontal defects. Specifically, the study aimed to assess the impact of LLLT on clinical outcomes, including probing depth reduction, clinical attachment level gain, and gingival recession, over a 12-month period. Additionally, it sought to investigate patient-reported outcomes such as pain perception and overall satisfaction with the treatment. By comparing the effects of standard flap surgery alone with those of surgery combined with LLLT, the study aimed to determine whether LLLT enhances the healing process and overall patient experience in periodontal therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcomes:
Probing Depth (PD) Assessment:
Preoperative baseline measurements of PD were recorded at six sites per tooth using a calibrated periodontal probe.
Follow-up measurements were taken at 3, 6, and 12 months post-surgery to evaluate changes in PD and assess the treatment's impact on periodontal pocket depth.
Clinical Attachment Level (CAL) Evaluation:
Initial CAL measurements were recorded at the same six sites per tooth, measuring from the cementoenamel junction to the base of the pocket.
Subsequent CAL assessments were conducted at the 3-month, 6-month, and 12-month follow-ups to determine alterations in attachment levels and quantify the success of the intervention.
Gingival Recession Measurement:
Gingival recession was assessed at baseline and during follow-up visits by measuring the distance from the gingival margin to the cementoenamel junction.
Changes in gingival recession were documented at the 3-month, 6-month, and 12-month intervals to ascertain any treatment-related effects on soft tissue recession.
Key secondary outcomes
Secondary Outcomes:
Pain Scores:
Patient-reported pain scores were collected using a standardized visual analog scale (VAS).
Participants recorded pain levels at specific postoperative time points (24 hours, 72 hours, 1 week, and 2 weeks) to capture the immediate and short-term impact of the combined surgical and LLLT intervention.
Overall Satisfaction:
Overall patient satisfaction was assessed through structured questionnaires, probing aspects such as aesthetics, functional improvement, and general contentment with the treatment outcome.
Surveys were administered at the 3-month, 6-month, and 12-month follow-ups to gauge the participants' long-term satisfaction with the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low level laser therapy during flap surgery for Intrabony defects
Interventions/Control_2
Standard periodontal flap surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants were individuals diagnosed with moderate to severe periodontitis, presenting with intrabony defects
Key exclusion criteria
Exclusion criteria comprised contraindications to LLLT, systemic conditions affecting periodontal health, and inability to comply with study requirements.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Hiroj |
| Middle name | Siddharth |
| Last name | Bagde |
Organization
Rama Dental College Hospital and Reseach Institute
Division name
Periodontology
Zip code
208024
Address
403, staff accomodations, Rama Dental College, Kanpur, Uttar pradesh
TEL
9766105900
hiroj.bagde@gmail.com
Public contact
Name of contact person
| 1st name | Hiroj |
| Middle name | Siddharth |
| Last name | Bagde |
Organization
Rama Dental college hospital and research centre
Division name
Periodontology
Zip code
208024
Address
Rama Dental College, Kanpur, Uttar pradesh
TEL
9766105900
Homepage URL
hirojbagde8@gmail.com
Sponsor or person
Institute
Rama Dental college hospital and research centre
Institute
Department
Personal name
Funding Source
Organization
Rama Dental college hospital and research centre
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rama Dental college hospital and research centre
Address
Rama Dental College, Kanpur, Uttar pradesh
Tel
9766105900
hirojbagde8@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
128
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060823
