Soft Tissue HealingNCT07415434
Laser-assisted Pontic Site Soft Tissue Healing Prior to Fixed Partial Denture Rehabilitation
A study testing GRR laser and Nd:YAG laser in people with Soft Tissue Healing, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Healing
- What is being tested?
- GRR laser and Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Faculty of Dentistry
Gaziantep, Turkey, 27310
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissue Healing
- Being tested
- GRR laser, Nd:YAG laser, Sham laser
- Keywords
- fixed partial denture, pontic site, low-level laser therapy, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRR laserDevice
Low-level laser therapy applied once daily for five consecutive days following tooth extraction to enhance soft tissue healing at the pontic site.
Nd:YAG laserDevice
Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction to promote soft tissue healing.
Sham laserOther
Placebo laser application performed under identical conditions without energy delivery.
| Study group | Role | What they receive |
|---|---|---|
| GRR Laser | Experimental | Laser therapy applied once daily for five consecutive days following tooth extraction. Receives: Device: GRR laser |
| Nd:YAG Laser | Experimental | Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction. Receives: Device: Nd:YAG laser |
| Placebo | Placebo comparator | Sham laser application performed under identical conditions without energy delivery. Receives: Other: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing index (Landry, Turnbull and Howley Healing Index)
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.
Measured: Baseline, Day 7, Day 14
Secondary outcomes (3)
Wound size reduction
Measurement of wound dimensions at the pontic site to evaluate soft tissue healing.
Measured: Baseline, Day 7, Day 14
Postoperative pain (VAS)
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.
Measured: Baseline, Day 7, Day 14
Gingival crevicular fluid TGF-β2 levels
Biochemical evaluation of transforming growth factor beta-2 levels in gingival crevicular fluid to assess biological aspects of wound healing.
Measured: Baseline, Day 7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Mar 2025
- Primary completion15 May 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue HealingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İREM KARAGOZOGLU, University of Gaziantep
- Investigators
- İREM KARAGÖZOĞLU, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415434
- Sponsor's protocol ID
- 2022/419
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karagozoglu I, Oz OP, Demirkol N, Tutus L, Tutus S, Demi̇rkol M. Laser-assisted pontic site soft tissue healing prior to fixed partial dentures: a randomized placebo-controlled clinical trial. BMC Oral Health. 2026 Jul 3. doi: 10.1186/s12903-026-09113-9. Online ahead of print.
PubMed 42399886
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser-Assisted Pontic Site Soft Tissue Healing Prior to Fixed Partial Denture Rehabilitation: A Randomized Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07415434
- Acronym / sponsor ID
- 2022/419
- Conditions
- Soft Tissue Healing
- Keywords
- fixed partial denture, pontic site, low-level laser therapy, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 17 Feb 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GRR Laser | Experimental | Device: GRR laserLaser therapy applied once daily for five consecutive days following tooth extraction. |
| Nd:YAG Laser | Experimental | Device: Nd:YAG laserNd:YAG laser therapy applied once daily for five consecutive days following tooth extraction. |
| Placebo | Placebo comparator | Other: Sham laserSham laser application performed under identical conditions without energy delivery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| GRR laserLow-level laser therapy applied once daily for five consecutive days following tooth extraction to enhance soft tissue healing at the pontic site. | Device | GRR Laser |
| Nd:YAG laserNd:YAG laser therapy applied once daily for five consecutive days following tooth extraction to promote soft tissue healing. | Device | Nd:YAG Laser |
| Sham laserPlacebo laser application performed under identical conditions without energy delivery. | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
Wound size reduction
Time frame: Baseline, Day 7, Day 14
Postoperative pain (VAS)
Time frame: Baseline, Day 7, Day 14
Gingival crevicular fluid TGF-β2 levels
Time frame: Baseline, Day 7, Day 14
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 17 Feb 2026.
- Derived from this study: PubMed 42399886Karagozoglu I, Oz OP, Demirkol N, Tutus L, Tutus S, Demi̇rkol M. Laser-assisted pontic site soft tissue healing prior to fixed partial dentures: a randomized placebo-controlled clinical trial. BMC Oral Health. 2026 Jul 3. doi: 10.1186/s12903-026-09113-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
İREM KARAGÖZOĞLU principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRR laser and Nd:YAG laser in people with Soft Tissue Healing, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 17 Feb 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Clinical healing index (Landry, Turnbull and Howley Healing Index) (time frame: Baseline, Day 7, Day 14). 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 NCT07415434, which also lists 1 linked publication.
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 17 Feb 2026.