Back to resultsEffect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Periowave®
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria: Age range from 18 to 65 years old; Patients with extensive periodontitis of the whole mouth; There was a deep periodontal pocket with PD≥5mm and at least one adjacent tooth at the extraction site; Periodontitis was controlled, and the extraction site and adjacent teeth were not in the acute inflammation or infection stage; The extraction site has a hopeless prognosis or no preservation value, and it is the first and second molars or maxillary wisdom teeth that erupt in a positive position Exclusion Criteria: pregnant and lactating women; patients with systemic diseases that may affect the ability of postoperative healing (such as patients with radiotherapy and chemotherapy, history of hematological diseases, and uncontrolled disease) Diabetes mellitus, etc.); long-term use of drugs known to affect bone metabolism or mucosal healing such as bisphosphonates and non-steroidal anti-inflammatory drugs; smoking > 10 cigarettes per day; root breakage or gingival tear occurred during tooth extraction.
Sites / Locations
- The Affiliated Stomatology Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
control group
Arm Description
Debridement of tooth extraction sockets was assisted by photodynamic equipment
Routine tooth extraction and debridement were performed
Outcomes
Primary Outcome Measures
Wound healing rate at 7 days
（The size of the tooth extraction wound area at 7 days）/(The size of the tooth extraction wound area at baseline)
Secondary Outcome Measures
Landry, Turnbull and Howley soft tissue healing index
Soft tissue index of healing wound after tooth extraction
Degree of pain
VAS score was used to evaluate the pain degree of tooth extraction trauma. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Changes in Bone Mineral density
Changes in Bone Mineral density
Bone height changes
Bone height changes
Wound healing rate at 14 days
（The size of the tooth extraction wound area at 14 days）/(The size of the tooth extraction wound area at baseline)
Full Information
NCT ID
NCT05664087
First Posted
December 15, 2022
Last Updated
September 14, 2023
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05664087
Brief Title
Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection
Official Title
Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Dental Hospital of Zhejiang University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Main Purpose: To evaluate the effect of photodynamic therapy on soft tissue healing after tooth extraction at periodontal infection site, and to compare the effect on pain degree and bone tissue remodeling after tooth extraction.
Detailed Description
The aim of this study is to evaluate the effect of photodynamic therapy (PDT) on soft tissue healing and bone remodeling in tooth extraction sockets after tooth extraction. The enrolled patients will be randomized into two groups. The control group used conventional tooth extraction to clean the wound, and the experimental group used photodynamic therapy to help clean the wound. Seven days and 14 days after extraction, the area of extraction socket was measured, the healing rate of extraction socket was calculated, and Landry, Turnbull and Howley soft tissue healing index was measured. The degree of pain was recorded at 6h, 1 day, 2 days and 3 days after tooth extraction. Bone remodeling indexes were measured at 1 month after tooth extraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Debridement of tooth extraction sockets was assisted by photodynamic equipment
Arm Title
control group
Arm Type
No Intervention
Arm Description
Routine tooth extraction and debridement were performed
Intervention Type
Drug
Intervention Name(s)
Periowave®
Other Intervention Name(s)
Photodynamic therapy
Intervention Description
The tooth extraction sockets were filled with photosensitizer methylene blue. The guide head of the laser periodontal therapy instrument (Piperway Laser periodontal therapy instrument) was placed in the tooth extraction sockets to probe and move around the tooth extraction sockets for 1 minute. At the end of irradiation, a cotton ball dipped in saline was used to wipe the guide head and rinse the photosensitizer out of the socket
Primary Outcome Measure Information:
Title
Wound healing rate at 7 days
Description
（The size of the tooth extraction wound area at 7 days）/(The size of the tooth extraction wound area at baseline)
Time Frame
baseline;at 7 days
Secondary Outcome Measure Information:
Title
Landry, Turnbull and Howley soft tissue healing index
Description
Soft tissue index of healing wound after tooth extraction
Time Frame
baseline, at 7 days; at 14days
Title
Degree of pain
Description
VAS score was used to evaluate the pain degree of tooth extraction trauma. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Time Frame
at 6 hours; at 1 day; at 2 days; at 3 days
Title
Changes in Bone Mineral density
Description
Changes in Bone Mineral density
Time Frame
baseline, at 1 month
Title
Bone height changes
Description
Bone height changes
Time Frame
baseline, at 1 month
Title
Wound healing rate at 14 days
Description
（The size of the tooth extraction wound area at 14 days）/(The size of the tooth extraction wound area at baseline)
Time Frame
baseline;at 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range from 18 to 65 years old;
Patients with extensive periodontitis of the whole mouth;
There was a deep periodontal pocket with PD≥5mm and at least one adjacent tooth at the extraction site;
Periodontitis was controlled, and the extraction site and adjacent teeth were not in the acute inflammation or infection stage;
The extraction site has a hopeless prognosis or no preservation value, and it is the first and second molars or maxillary wisdom teeth that erupt in a positive position
Exclusion Criteria:
pregnant and lactating women;
patients with systemic diseases that may affect the ability of postoperative healing (such as patients with radiotherapy and chemotherapy, history of hematological diseases, and uncontrolled disease) Diabetes mellitus, etc.);
long-term use of drugs known to affect bone metabolism or mucosal healing such as bisphosphonates and non-steroidal anti-inflammatory drugs;
smoking > 10 cigarettes per day;
root breakage or gingival tear occurred during tooth extraction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen YIxu, master
Phone
0571-87219287
Email
kyb@zjkq.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihui Ding, Doctor
Organizational Affiliation
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihui Ding, Doctor
Phone
18957108518
Email
phding@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection
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