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Completed

NCT Number: NCT05664087

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: The disposable dental Treatment Kits Paiwei™(Zhengzhou Gata biotechnology Co.,Ltd.,China)

Primary outcomes

  1. Wound healing rate at 7 days

    Time frame: baseline;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 outcomes

  1. Landry, Turnbull and Howley soft tissue healing index

    Time frame: baseline, at 7 days; at 14days

    Soft tissue index of healing wound after tooth extraction

  2. Degree of pain

    Time frame: at 6 hours; at 1 day; at 2 days; at 3 days

    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.

  3. Changes in Bone Mineral density

    Time frame: baseline, at 1 month

    Changes in Bone Mineral density

  4. Bone height changes

    Time frame: baseline, at 1 month

    Bone height changes

  5. Wound healing rate at 14 days

    Time frame: baseline;at 14 days

    (The size of the tooth extraction wound area at 14 days)/(The size of the tooth extraction wound area at baseline)

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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