Periodontitis Clinical Trial
Official title:
Comparative Evaluation of Minimally Invasive Nonsurgical Periodontal Therapy Versus Conventional Subgingival Instrumentation in Patients With Generalized Stage 2 and 3 Periodontitis - A Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | November 10, 2023 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion criteria- - 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. Exclusion criteria- - 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 |
Country | Name | City | State |
---|---|---|---|
India | Post graduate institute of dental sciences | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PROBING POCKET DEPTH(PPD) | It will be measured as the distance from the gingival margin to the base of the pocket using the calibrated manual periodontal probe (PCP-UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of the involved teeth- mesiobuccal, midbuccal, distobuccal, mesiolingual, distolingual and midlingual. | 6 WEEKS AND 3 MONTHS | |
Secondary | CLINICAL ATTACHMENT LEVEL(CAL) | It will be measured from cemento-enamel junction to base of the pocket. Measurements will be made at 6 sites of the involved tooth- mesiobuccal, midbuccal, distobuccal, mesiolingual, distolingual and midlingual. The mean clinical attachment loss over all examined surfaces will be calculated. | 6 WEEKS AND 3 MONTHS | |
Secondary | GINGIVAL RECESSION(REC) | Gingival recession was measured as the distance from the Cementoenamel junction(CEJ) to the gingival margin (GM), parallel to the long axis of the tooth starting from the most apical point of recession. | 6 WEEKS AND 3 MONTHS |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04712630 -
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
|
N/A | |
Completed |
NCT06127069 -
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
|
N/A | |
Completed |
NCT04964167 -
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
|
Phase 4 | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Recruiting |
NCT03997552 -
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
|
N/A | |
Completed |
NCT05530252 -
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
|
Phase 4 | |
Completed |
NCT04881357 -
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
|
N/A | |
Recruiting |
NCT03790605 -
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
|
Phase 3 | |
Enrolling by invitation |
NCT04971174 -
Outcomes of Periodontal Regenerative Treatment
|
||
Not yet recruiting |
NCT05568290 -
Interleukin-38 Levels in Individuals With Periodontitis
|
||
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Recruiting |
NCT03997578 -
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
|
N/A | |
Completed |
NCT03901066 -
Smoking Dependence and Periodontitis
|
||
Enrolling by invitation |
NCT04956211 -
Periodontal Treatment and Ischemic Stroke
|
N/A | |
Recruiting |
NCT05971706 -
Ozone Application in Periodontal Treatment
|
N/A | |
Recruiting |
NCT06099574 -
A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
|
||
Completed |
NCT04402996 -
Meteorin-like Levels in Individuals With Periodontitis
|
||
Active, not recruiting |
NCT05311657 -
Oral Health and Severe COPD
|
||
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Not yet recruiting |
NCT05643287 -
The Effect of Time on the Outcome of Periodontal Treatment.
|
N/A |