Comparative Evaluation of Minimally Invasive Nonsurgical Periodontal Therapy Versus Conventional Subgingival Instrumentation

NCT05876455 | Unknown DMC

• 1 other identifier: RitikaArora23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background- The use of minimally invasive procedures has recently been advocated for the treatment of periodontitis, to minimize patient discomfort and maximize the healing potential. These techniques usually involve the use of magnification lenses or microscopes and small instruments which reduce the risk of tissue trauma compared with traditional instruments. Rationale- So far only descriptive data about the clinical effects of such procedure are available and comparative studies that would include other treatment alternatives are lacking. Therefore, the aim of this study is, on split-mouth model, to compare the number of diseased sites (defined by probing depth ˃ 4 mm and bleeding on probing) after conventional subgingival instrumentation and Minimally invasive nonsurgical periodontal therapy (MINST) with the usage of special mini instruments and magnifying loupes. Objectives- To compare sites that have residual probing depth and require further surgical intervention after undergoing the two treatment modalities. Methods- In this split mouth randomized controlled trial, Test group will undergo non surgical therapy under magnification and using special mini bladed instruments while the control group will undergo conventional subgingival instrumentation. Reevaluation will be at 6 weeks and 3 months. Expected outcomes- If both the groups differ in outcomes after therapy, MINST can be used to minimize the number of sites that require surgery and hence will reduce treatment costs and morbidity.

Conditions

Periodontitis; Subgingival Plaque

Outcome Measures

Primary Outcomes (1)

• Number of diseased sites

  Difference in No of Sites with PPD (probing pocket depth) \> 4 mm and BOP (bleeding upon probing)

  6 weeks and 3 months

Secondary Outcomes (3)

• PROBING POCKET DEPTH(PPD)

  6 WEEKS AND 3 MONTHS

• CLINICAL ATTACHMENT LEVEL(CAL)

  6 WEEKS AND 3 MONTHS

• GINGIVAL RECESSION(REC)

  6 WEEKS AND 3 MONTHS

Study Arms (2)

Control group

ACTIVE COMPARATOR

On the conventional non-surgical periodontal therapy side, a power-driven piezo-electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus, and manual standard Gracey curette instruments (Gracey curettes Hu-Friedy, Chicago, IL, USA) will be used to remove residual deposits from the root surface.

Procedure: Conventional Subgingival Instrumentation

Test Group

ACTIVE COMPARATOR

Experimental sites designated to receive minimally invasive non-surgical periodontal therapy will undergo careful scaling and root planing under magnification (use of 3.5 X magnification loupes) with mini curettes and using an ultrasonic device with specific thin and delicate tips. These instruments will be carefully inserted through the periodontal pocket of the affected tooth to reach the root surface for debridement. Caution will be taken to preserve the stability of soft tissues.

Procedure: minimally invasive non-surgical periodontal therapy

Interventions

Conventional Subgingival Instrumentation PROCEDURE

On the conventional non-surgical periodontal therapy side, a power-driven piezo-electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus, and manual standard Gracey curette instruments (Gracey curettes Hu-Friedy, Chicago, IL, USA) will be used to remove residual deposits from the root surface.

Control group

minimally invasive non-surgical periodontal therapy PROCEDURE

minimally invasive non-surgical periodontal therapy will undergo careful scaling and root planing under magnification (use of 3.5 X magnification loupes) with mini curettes and using an ultrasonic device with specific thin and delicate tips. These instruments will be carefully inserted through the periodontal pocket of the affected tooth to reach the root surface for debridement. Caution will be taken to preserve the stability of soft tissues.

Test Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients having generalised Stage 2 or stage 3 periodontitis according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification
• A full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<20%, at least 5 teeth in each quadrant.

You may not qualify if:

• pregnant or lactating
• requiring antibiotic premedication
• received antibiotic treatment in the previous 3 months
• received a course of periodontal treatment within the past 6 months
• smokers
• signs of mobility and/or traumatic occlusion

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post graduate institute of dental sciences

Rohtak, Haryana, 110015, India

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ritika Arora, MDS

  PGIDS,ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ritika Arora, MDS

CONTACT

9810734445; drritika44@gmail.com

Deepti Anand, MDS

CONTACT

9466626426; deeptianand777@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 25, 2023
• Study Start: July 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: November 10, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

IN (1)