PeriodontitisNCT05664087

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

A study testing Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw. in people with Periodontitis, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Periodontitis
What is being tested?: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteChina
Study dates: 14 Feb 2023to 1 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

Read the 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.

Conditions: Periodontitis
Being tested: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.Drug
Also called The disposable dental Treatment Kits Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China）
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

Study groups in NCT05664087
Study group	Role	What they receive
Experimental group	Experimental	Debridement of tooth extraction sockets was assisted by photodynamic equipment Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: baseline;at 7 days

Secondary outcomes (5)

Landry, Turnbull and Howley soft tissue healing index
Soft tissue index of healing wound after tooth extraction
Measured: 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.
Measured: at 6 hours; at 1 day; at 2 days; at 3 days
Changes in Bone Mineral density
Changes in Bone Mineral density
Measured: baseline, at 1 month
Bone height changes
Bone height changes
Measured: 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)
Measured: baseline;at 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20231 Nov 2023

First posted23 Dec 2022
Study start14 Feb 2023
Primary completion1 Nov 2023
Study completion1 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05664087
Sponsor's protocol ID: DHZhejiangU-2022(197)
Status last verified: Aug 2025
First submitted: 15 Dec 2022
Last updated: 24 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
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Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection: a Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05664087
Acronym / sponsor ID: DHZhejiangU-2022(197)
Conditions: Periodontitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
Study start: 14 Feb 2023 (actual)
Primary completion: 1 Nov 2023 (actual)
Study completion: 1 Nov 2023 (actual)
First posted: 23 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.Debridement of tooth extraction sockets was assisted by photodynamic equipment
control group	No intervention	–Routine tooth extraction and debridement were performed

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.Also: The disposable dental Treatment Kits Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China）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	Drug	Experimental group

Primary outcome

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)

5 secondary outcomes

Landry, Turnbull and Howley soft tissue healing index
Time frame: baseline, at 7 days; at 14days
Degree of pain
Time frame: at 6 hours; at 1 day; at 2 days; at 3 days
Changes in Bone Mineral density
Time frame: baseline, at 1 month
Bone height changes
Time frame: baseline, at 1 month
Wound healing rate at 14 days
Time frame: baseline;at 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
Individual participant dataSharing planned: No

Related trials for Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peihui Ding, Doctor principal investigator

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound healing rate at 7 days (time frame: baseline;at 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05664087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.