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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664087
• Other study ID #: DHZhejiangU-2022(197)
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: Chen YIxu, master
• Phone: 0571-87219287
• Email: kyb[@]zjkq.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Periowave®
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

Locations

Country	Name	City	State
China	The Affiliated Stomatology Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Landry, Turnbull and Howley soft tissue healing index	Soft tissue index of healing wound after tooth extraction	baseline, at 7 days; at 14days
Secondary	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
Secondary	Changes in Bone Mineral density	Changes in Bone Mineral density	baseline, at 1 month
Secondary	Bone height changes	Bone height changes	baseline, at 1 month
Secondary	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