NCT07415434

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 9, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

fixed partial denturepontic sitelow-level laser therapyclinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Day 7, Day 14

Secondary Outcomes (3)

  • Wound size reduction

    Baseline, Day 7, Day 14

  • Postoperative pain (VAS)

    Baseline, Day 7, Day 14

  • Gingival crevicular fluid TGF-β2 levels

    Baseline, Day 7, Day 14

Study Arms (3)

GRR Laser

EXPERIMENTAL

Laser therapy applied once daily for five consecutive days following tooth extraction.

Device: GRR laser

Nd:YAG Laser

EXPERIMENTAL

Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction.

Device: Nd:YAG laser

Placebo

PLACEBO COMPARATOR

Sham laser application performed under identical conditions without energy delivery.

Other: Sham laser

Interventions

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.

GRR Laser

Nd:YAG laser therapy applied once daily for five consecutive days following tooth extraction to promote soft tissue healing.

Nd:YAG Laser

Placebo laser application performed under identical conditions without energy delivery.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University Faculty of Dentistry

Gaziantep, Turkey, 27310, Turkey (Türkiye)

Location

Study Officials

  • İREM KARAGÖZOĞLU

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.prof.

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

March 15, 2025

Primary Completion

May 15, 2025

Study Completion

June 15, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations