CClinicalTrials.gg
Status unknownNCT04358887Updated Apr 24, 2020

Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery

An interventional study of piezoelectric surgery and conventional bur in Periapical Disease, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Dec 2018, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study summary

This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.

Read the detailed description

The goal of endodontic surgery has changed from mere reduction of periapical pathosis and preservation of periodontium to successful postoperative management of patient regarding function and esthetics, improving the quality of life of patient and their overall acceptance. Piezoelectric bone surgery is a recent and innovative technology, permitting selective cutting of mineralized tissues sparing soft tissues.In this study after thorough clinical \& radiographic examination patients will be given informed consent after explaining the treatment procedure and its associated risks and benefits. Patients are allocated into 2 groups, group 1(piezo group) in which after flap reflection bone cutting and root end cutting are performed with US6 piezoelectric insert and in group 2(control) bone and root end cutting are performed with conventional bur. Each patient will be given a questionnaire to fill out for each day starting from the day of surgery for 7 days postoperatively to assess the quality of life. They will be also requested to note down the details of analgesic intake. Hemorrhage control during surgery will be assesed. Clinical and radiographic examinations will be performed every 3, 6 and 12 months to evaluate any evidence of signs and/or symptoms and after 12 month follow up post operative CBCT taken to evaluate volume reduction of lesion postoperatively.

02

Conditions studied

  • Periapical Disease

Browse trials for

Keywords

  • piezoelectric surgery, quality of life, hemostasis
03

In context

Periapical Diseases

44 studies on the registry are indexed under Periapical Diseases; 12 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 35 interventional studies indexed under Periapical Diseases.

Browse Periapical Diseases studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients with no general medical contra-indications for oral surgical procedures (ASA-1 or ASA-2).
  2. Patients of age 16 years and above.
  3. The tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis).
  4. The nonsurgical re-treatment was judged unfeasible or had previously failed.
  5. The tooth had an adequate final restoration with no clinical evidence of coronal leakage.
  6. The apical area of the root canal should be devoid of the presence of a post for at least 6 mm.
  7. Patients with no acute symptoms.

Exclusion criteria

Exclusion Criteria:

  1. Unrestorable tooth.
  2. Fractured / perforated tooth.
  3. Apicomarginal defects.
  4. Through \& through lesions.
  5. Teeth with deep pockets.
  6. Serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    periapical surgery with piezo.

    After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert

    Procedure: piezoelectric surgery

  • Active comparator
    Periapical surgery with bur.

    After flap reflection bone and root end cutting are done with surgical bur.

    Procedure: conventional bur

Interventions

  • Procedurepiezoelectric surgery

    after flap reflection bone and root end cutting are done with piezoelectric surgical insert

  • Procedureconventional bur

    after flap reflection bone and root end cutting are done with surgical bur

06

What researchers measure

Primary outcomes

  1. Quality of life assessment

    By quality of life questionnaire(Igor Tsesis et al)

    Time frame: Till 1 week after surgery

  2. Postoperative healing

    2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria

    Time frame: 12 months

Secondary outcomes

  1. hemorrhage control

    assessed by scores used by Vy et al

    Time frame: during surgery

07

Study locations

1 site
  • Post graduate institute of dental sciences
    Rohtak, Haryana 124001, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04358887
Lead sponsor
Postgraduate Institute of Dental Sciences Rohtak
Responsible party
Sponsor
First posted
Apr 24, 2020
Start date
Dec 1, 2018
Primary completion
Apr 30, 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Apr 24, 2020

Study contacts

JAYA BHARATHI
principal investigator · POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion