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

August 19, 2025 updated by: Peihui Ding, The Dental Hospital of Zhejiang University School of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chen YIxu, master
  • Phone Number: 0571-87219287
  • Email: kyb@zjkq.com.cn

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
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.
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）
No Intervention: control group
Routine tooth extraction and debridement were performed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
baseline;at 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline, at 7 days; at 14days
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.
at 6 hours; at 1 day; at 2 days; at 3 days
Changes in Bone Mineral density
Time Frame: baseline, at 1 month
Changes in Bone Mineral density
baseline, at 1 month
Bone height changes
Time Frame: baseline, at 1 month
Bone height changes
baseline, at 1 month
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)
baseline;at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Dental Hospital of Zhejiang University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peihui Ding, Doctor, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DHZhejiangU-2022(197)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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