Clinical trial NCT02896283: Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft
Official title: The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gingival Recession
Keywords: wound healing
low-level laser therapy
gingival recession
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.

Detailed description: Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening. However, patient discomfort during the healing time is a major disadvantage of this procedure. Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery. Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures. However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.

Eligibility criteria: Inclusion Criteria:

* lack of keratinized tissue around teeth (bilateral)

Exclusion Criteria:

* patients with systemic diseases
* non-cooperative patients
* smokers
* poor oral hygiene
* root surface restorations or active caries

Primary outcomes:
measure: degree of epithelialization
timeFrame: At day 7
measure: degree of epithelialization
timeFrame: At day 14
measure: degree of epithelialization
timeFrame: At day 21
Secondary outcomes:
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 1
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 2
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 3
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 4
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 5
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 6
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 7
measure: Visual analogue scale (VAS) pain score
timeFrame: at day 14
measure: Clinical healing
timeFrame: at day 1
measure: Clinical healing
timeFrame: at day 2
measure: Clinical healing
timeFrame: at day 7
measure: Clinical healing
timeFrame: at day 14
measure: Clinical healing
timeFrame: at day 21
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Neda Moslemi
Study officials:
affiliation: Laser Research Center of Dentistry, Tehran University of Medical Sciences
name: Neda Moslemi
role: STUDY_DIRECTOR
References: