Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection: a Randomized Controlled Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Periowave®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Debridement of tooth extraction sockets was assisted by photodynamic equipment | Drug: Periowave®<br>* 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<br>* Other names: Photodynamic therapy;|
| No Intervention: control group<br>Routine tooth extraction and debridement were performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline;at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Landry, Turnbull and Howley soft tissue healing index | Soft tissue index of healing wound after tooth extraction | baseline, at 7 days; at 14days | 
| 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. | at 6 hours; at 1 day; at 2 days; at 3 days | 
| Changes in Bone Mineral density | Changes in Bone Mineral density | baseline, at 1 month | 
| Bone height changes | Bone height changes | baseline, at 1 month | 
| 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) | baseline;at 14 days |