Comparative Evaluation of Osseous Resection by Piezoelectric Device Versus Conventional Rotary Instruments

NCT03916653 | Unknown DMC

• 1 other identifier: prinita perio
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to comparatively evaluate changes in periodontal healing, surgical time required and postoperative morbidity observed in patients undergoing osseous resection in crown lengthening procedure with conventional rotary instruments versus piezoelectric device.

Conditions

Healing Surgical Wounds

Outcome Measures

Primary Outcomes (3)

• Postoperative patient perceived outcomes

  Postoperative pain using visual analog scale at treated site (VAS; a scale from 0-10; 0 means no pain/discomfort, 10 means maximum pain/discomfort)at 1st day, 4th day and 7th day postoperative..

  7 days

• Gain in crown length

  Free gingival margin(FGM; measured before surgery and after suturing i.e distance from stent to free gingival margin)

  6 months

• Change in alveolar bone level

  Intra oral periapical radiographic evaluation of alveolar bone level will be done at baseline, after surgery and 6 months post-operatively. By taking CEJ (cement enamel junction) as a fixed reference point to alveolar bone crest, bone level will be measured at various time periods using image j software. Standardised intraoral periapical radiographs will be taken by using customized bite block with paralleling angle technique using Rinn XCP holder.

  6 months

Secondary Outcomes (1)

• Stability of supracrestal gingival tissues

  6 months

Study Arms (2)

Test group

EXPERIMENTAL

Osseous resection using piezoelectric device

Procedure: osseous resection using piezoelectric device in surgical crown lengthening

Control group

ACTIVE COMPARATOR

Osseous resection using conventional rotary instruments

Procedure: Osseous resection using conventional rotary instruments in surgical crown lengthening

Interventions

osseous resection using piezoelectric device in surgical crown lengthening PROCEDURE

In this group piezoelectric device will be used for osseous resection in crown lengthening procedure with copious irrigation of sterile saline.

Test group

Osseous resection using conventional rotary instruments in surgical crown lengthening PROCEDURE

For osseous resection in crown lengthening procedure, conventional rotary instruments will be used with copious irrigation of sterile saline.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-60years
• plaque index(PI) \<129
• gingival index(GI)\<132
• short clinical abutment tooth
• crown and root fractured tooth
• tooth needed for restorative rehabilitation

You may not qualify if:

• Patients with systemic diseases (eg. Diabetes mellitus, hypertension, cancer patients etc.)
• Smokers
• Teeth requiring crown lengthening having adjacent tooth/teeth missing.
• Pregnant and lactating women. .Tooth mobility and furcation involvement.
• Active orthodontic therapy
• Presence of attachment loss/non restorable tooth

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Shikha Tewari

Rohtak, Haryana, 124001, India

Location

Study Officials

• Shikha Tewari, MDS

  PGIDS,ROHTAK

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: February 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-04

Locations

IN (1)