- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415434
Laser-assisted Pontic Site Soft Tissue Healing Prior to Fixed Partial Denture Rehabilitation
February 16, 2026 updated by: İREM KARAGOZOGLU, University of Gaziantep
Laser-Assisted Pontic Site Soft Tissue Healing Prior to Fixed Partial Denture Rehabilitation: A Randomized Placebo-Controlled Clinical Trial
This randomized placebo-controlled clinical trial aimed to evaluate the effect of laser-assisted therapy on soft tissue healing at the pontic site prior to fixed partial denture rehabilitation.
Clinical healing outcomes, postoperative pain levels, and gingival crevicular fluid transforming growth factor beta-2 (TGF-β2) levels were assessed to determine the biological and clinical effects of laser therapy compared with placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Delayed or compromised soft tissue healing at the pontic site may prolong prosthetic treatment and negatively affect tissue stability and patient comfort.
Photobiomodulation has been reported to enhance wound healing and modulate inflammatory and regenerative processes.
This randomized placebo-controlled clinical trial evaluated the clinical and biological effects of laser-assisted therapy on pontic site healing prior to fixed partial denture rehabilitation.
Clinical healing index scores, wound dimensions, postoperative pain levels, and gingival crevicular fluid TGF-β2 levels were assessed to investigate both clinical and biological aspects of healing.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- 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 Locations
-
-
Turkey
-
Gaziantep, Turkey, Turkey (Türkiye), 27310
- Gaziantep University Faculty of Dentistry
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Patients requiring single-tooth extraction followed by fixed partial denture rehabilitation
- Patients in good general health
- Patients willing to participate and able to provide informed consent
Exclusion Criteria:
- Presence of systemic diseases that may affect wound healing (e.g., uncontrolled diabetes, immunological disorders)
- Active periodontal disease at the study site
- Use of medications affecting wound healing
- Smoking or tobacco use
- Pregnancy or lactation
- History of radiotherapy in the head and neck region
- Known contraindications to laser therapy
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GRR Laser
Laser therapy applied once daily for five consecutive days following tooth extraction.
|
Low-level laser therapy applied once daily for five consecutive days following tooth extraction to enhance soft tissue healing at the pontic site.
|
|
Experimental: Nd:YAG Laser
Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction.
|
Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction to promote soft tissue healing.
|
|
Placebo Comparator: Placebo
Sham laser application performed under identical conditions without energy delivery.
|
Placebo laser application performed under identical conditions without energy delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical healing index (Landry, Turnbull and Howley Healing Index)
Time Frame: Baseline, Day 7, Day 14
|
Clinical healing was assessed using the Landry, Turnbull and Howley Healing Index, which provides a single composite ordinal score ranging from 1 to 5, where higher scores indicate better soft tissue healing.
The score is determined based on clinical evaluation of tissue color, bleeding on palpation, presence of granulation tissue, and degree of epithelialization at the pontic site.
|
Baseline, Day 7, Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound size reduction
Time Frame: Baseline, Day 7, Day 14
|
Measurement of wound dimensions at the pontic site to evaluate soft tissue healing.
|
Baseline, Day 7, Day 14
|
|
Postoperative pain (VAS)
Time Frame: Baseline, Day 7, Day 14
|
Postoperative pain intensity was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Baseline, Day 7, Day 14
|
|
Gingival crevicular fluid TGF-β2 levels
Time Frame: Baseline, Day 7, Day 14
|
Biochemical evaluation of transforming growth factor beta-2 levels in gingival crevicular fluid to assess biological aspects of wound healing.
|
Baseline, Day 7, Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İREM KARAGÖZOĞLU, University of Gaziantep
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)
March 15, 2025
Primary Completion (Actual)
May 15, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
February 9, 2026
First Submitted That Met QC Criteria
February 16, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 16, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2022/419
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
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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