Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05108727 |
| Other study ID # |
2012-21-008 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
March 2020 |
Study information
| Verified date |
November 2021 |
| Source |
Bulent Ecevit University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The authors theorize that periodontal flap surgery therapy with adjunctive DL therapy might
bring favourable therapy results (clinical and bacterial parameters) in patients with stage
3-grade C periodontitis. Therefore, the goal of this split-mouth randomized clinical trial
was to evaluate and compare the effectiveness of the treatment results for DL assisted
modified Widman Flap (MWF) surgery (test site) with MWF surgery alone (control site) in
periodontitis patients with stage 3-grade C by determining the changes in clinical parameters
and bacterial load of pathogens (P.g., T.d., Camplyobacter rectus (C.r.), Prevotella
intermedia (P.i.), T.f., A.a.) at preoperative and following MWF surgery at 6th week, 3rd and
6th months
Description:
A randomised control split-mouth study were performed at the Department of Periodontology,
Faculty of Dentistry, Bülent Ecevit University, Zonguldak, Turkey, between January 2013 and
February 2016.After clinical evaluation, a total of 30 subjects, who showed signs of stage
3-grade C periodontitis, were enrolled to this study at baseline. These patients were
underwent a full mouth scaling and root planning (SRP). Six weeks after non surgical
periodontal therapy, periodontal assessment was performed to confirm the suitability of the
sites for periodontal surgery. This split-mouth study was conducted in 18 patients with stage
3 Grade C periodontitis aged between 22 and 35 years.
Before the surgery, the selected quadrants were randomly allocted (by the toss of a coin)
into test and control sites where the control site were treated with MWF+sham application of
DL and test sites were treated with MWF+ active DL. Clinical parameters including CAL, PD,
plaque index(PI), gingival index(GI), bleeding on probing (BOP) were recorded and
microbiological sampling were obtained at preoperative and at 6 weeks, 3 months, 6 months
postoperatively. Pain scale assessment (visual analog scale, VAS), pain medication
consumption (PM), tissue edema (TE), and tissue color (TC) were evaluated one week following
surgery. Microbiological analysis was done by real-time polymerase chain reaction (PCR) for
detection of Porphyromonas gingivalis (P.g.), Treponema denticola (T.d.), Tannerella
forsythia (T.f.), Camplyobacter rectus (C.r.), Prevotella intermedia (P.i.), Aggregatibacter
actinomycetemcomitans (A.a.).
Control sites were treated MWF with sham application of DL, while test sites were treated MWF
with the applying of active DL (810nm±5, Picasso-AMD, USA) to the inside of the MWF. The
interval between the two surgeries was 3 weeks. The modified Widman flap technique was
applied.DL with a wavelength of 810±5 nm and a power of 1 watt in continuous mode was applied
to the MWF at the test sites. A 400 micron diameter tip was used to remove all visible
epithelium on the inside of the flap from the free gingival edge to the lower apical aspect
of the flap (both labial and lingual / palatal). The tip was started using a blue
articulating paper. DL irradiation performed at a 45o angle to the soft tissue flap to avoid
any laser (810nm±5) contact to the root surface or the alveolar bone . DL therapy was carried
out to soft tissue from the coronal to the apical aspect in parallel paths for 10seconds.
When irradiation exceeded 10 seconds in time, laser (810nm) emission was be interrupted for
30 seconds. The resultant char layer was be totally removed with moist gauze prior to
replacing the flaps. A second laser application with the same laser (810nm±5) was performed
on all the surfaces of the flap in continuous mode at 0.1 watts. All surfaces of the flap,
inner and outer, exposed bone and exposed root structures involved in the surgery were
irradiated, leading to a total dosage of 4 J/cm2 per surface.
The subjects were prescribed 200 mg Ibuprofen (up to 3 tablets) every 8 hours to reduce pain.
The subjects were instructed not to eat solid food using the treated area and to not brush
the teeth in the treated area. They were told to rinse their mouth with chlorhexidine
digluconate (0.2%, CHX) twice a day for 1 min during one week after surgery The sutures were
removed at first week . After 1 weeks, the subject started brushing their teeth and oral
hygiene training was repeated. Oral hygiene instructions were provided at each postoperative
visit.
