- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03028727
Diode Laser Therapy As An Adjunct To Scaling And Root Planing
Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.
The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
- Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm
Exclusion Criteria:
- Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
- Subjects on antibiotics or immunosuppressants.
- Chronic smokers, alcoholics, smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women
- Subjects who had undergone extensive restorative dental treatment.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Ultrasonic Scaling, Root planing
Ultrasonic Scaling and Root planing at day 0 and at 1 week.
|
Procedure of scaling and root planing at day 0 and at 1 week
|
|
Experimentell: 980 nm diode Laser irradiation
Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.
|
Procedure of scaling and root planing at day 0 and at 1 week
Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in levels of P.gingivalis
Tidsram: 14 weeks
|
Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
|
14 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in gingival index
Tidsram: 14 weeks
|
Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
|
14 weeks
|
|
Change in plaque index
Tidsram: 14 weeks
|
Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
|
Change in probing pocket depth
Tidsram: 14 weeks
|
Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
|
Change in clinical attachment level
Tidsram: 14 weeks
|
Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KLESocietyIDS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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