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临床试验/CTRI/2017/09/009736
CTRI/2017/09/009736尚未招募1/2 期

Comparative evaluation of Laser-Assisted New Attachment procedure and Excisional New Attachment procedure for the treatment of Periodontal Pockets. A Randomised Split Mouth Clinical Trial

未提供1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年2月10日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
入组人数
15
试验地点
1
主要终点
To compare the clinical outcomes of LANAP versus ENAP and SRP procedures among study population.

研究概览

简要总结

**AIM:**The aim of the present study is toevaluate the clinical effect of laser assisted new attachment procedure versus excisionalnew attachment procedure in the treatment of moderate periodontal pockets.

METHOD:

All the patients will be explained aboutthe aim, nature, and design of the study along with a written informed consentfor their participation before the commencement of the study.

Thestudy is planned as a single centre, longitudinal, triple masked (investigators,subjects and statistician), randomized parallel arm design. The study durationis 6 months in which the clinical parameters will be recorded at baseline, 1month, 3 months, 6 months

The clinical parameters for considerationincludes plaque index (Silness and Loe 1964), gingival bleeding index (Muehlemannand Son 1971), pocket depth and clinical attachment level,  and healing index(landry,Turnbull and Howley),VAS

Threesites with pocket depth of 5 mm or above will be selected for the study. Theselected sites will be randomized  intothree groups. (Group A, B & C). The randomization will be done using acomputer generated random table

Group A (control site): SRP

Group B (test site): SRP with ENAP

Group C (test site): SRP with LANAP

TREATMENTPROCEDURE:

ENAP: After scaling and root planning, underadequate local anaesthesia pocket marking will be performed to delineate thedepth of the incision. A scalloped, internally-bevelled, partial thick-nessincision will be made from crest of the free gingival margin to the base ofpocket in the area being treated. The excised tissue and all of thegranulomatous tissue within the area of the pocket will be removed with acurette. The root surfaces are then scaled and planed to a smooth, hardconsistency to the base of incision. The gingival tissue is then repositionedagainst the tooth as closely as possible and if required the wound edges shouldbe secured with sutures and periodontal dressing.

LANAP:After scaling and root planning, diode laser will be first used on a setting of4.0 W, 100-microseconds pulse duration, and 20 Hz. It is passed from gingivalmargin to the base of the pocket parallel to the root surface and movedlaterally and apically to remove the diseased pocket epithelium anddecontaminate the pocket. A second pass with the laser on to the setting of 4.0W, 650-microseconds pulse duration, and 20 Hz was performed to form a fibrinclot and then the tissue will be compressed against the tooth for closer approximation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • The individuals aged 25 to 60 years.
  • Subjects with at least 20 natural permanent teeth History of no periodontal treatment in last 12 months Should have at least probing depth equal to or more than 5mm.

排除标准

  • Systemic diseases that could influence the outcome of periodontal therapy Smokers Pregnancy and Lactating women.
  • Poor oral hygiene and failure to comply with protocol.

结局指标

主要结局

To compare the clinical outcomes of LANAP versus ENAP and SRP procedures among study population.

时间窗: 1 month, 3 months, 6 months

次要结局

  • To compare patients response following ENAP and LANAP(1 month)

研究者

发起方
未提供

研究点 (1)

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