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

NCT05664087 | Completed

• 1 other identifier: DHZhejiangU-2022(197)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Landry, Turnbull and Howley soft tissue healing index

  baseline, at 7 days; at 14days

• Degree of pain

  at 6 hours; at 1 day; at 2 days; at 3 days

• Changes in Bone Mineral density

  baseline, at 1 month

• Bone height changes

  baseline, at 1 month

• Wound healing rate at 14 days

  baseline;at 14 days

Study Arms (2)

Experimental group

EXPERIMENTAL

Debridement of tooth extraction sockets was assisted by photodynamic equipment

Drug: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.

control group

NO INTERVENTION

Routine tooth extraction and debridement were performed

Interventions

Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw. DRUG

The tooth extraction sockets were filled with photosensitizer methylene blue. The guide head of the laser periodontal therapy instrument (Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.) 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

Also known as: The disposable dental Treatment Kits Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China）

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Peihui Ding, Doctor

  The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: February 14, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)