Useful bacteria and laser in Gum Disease
- Conditions
- chronic periodontitis
- Registration Number
- CTRI/2018/05/013597
- Lead Sponsor
- vellampalli udhaya bhanu
- Brief Summary
The aim of thestudy was to evaluate the clinical and microbiological efficacy of probioticbacteria with and without photodynamic therapy as an adjunct to scaling androot planning in patients with chronic periodontitis.
The objective ofthe current study is to reduce the sub-gingival pathogenic microorganisms bylocal administration of beneficial bacteria subgingivally with and withoutphotodynamic therapy concomitantly to phase-1 periodontal therapy.
A double masked, randomized controlled clinical trialwill be conducted with a sample size of 100 between the age limit of 25-60years will be selected from the outpatient unit of department of periodontologybased on the following criteria.
All the patients will be explained about the aim,nature, and design of the study along with a written informed consent for theirparticipation before the commencement of the study.
Theclinical parameters for consideration includes plaque index (Silness and Loe1964), gingival index (Loe and silness1963), modified sulcular gingival bleeding index (Mombelli,&oosten1987),pocket depth and clinical attachment level will be assessed at baseline. Athorough SRP will be performed in all the patients.AfterSRP the subjects will be randomly allocated togroup A,B,C,D based on computer generated randomized table.
**TREATMENTPROCEDURE**:
AfterSRP, PDT will be performed with diode laser in combination with photosensitizerdye.Periodontal pockets will be filled with thephotosensitizer employing a blunt cannula starting from the bottom of thepocket to achieve both, complete filling of the pocket and coating of the rootsurface. After 3 minutes residence time, the pockets will be rinsed with waterto remove excess photosensitizer. The remaining photosensitizer will beactivated with the laser probe for 10 seconds. Probiotics will be inserted intoperiodontal pocket.
**CONTROL GROUP (A) : ONLY SRP**
**TEST GROUP (B): SRP+PDT TEST GROUP (C): SRP+PROBIOTICS**
**TEST GROUP (D):SRP +PROBIOTICS +PDT.**
Thepatients will be recalled after 3months for further evaluation of periodontalclinical parameters. In addition to evaluation of clinical parameters,periodontal pathogenic microbiological evaluation will be performed at bothbaseline and at 3months. The obtained data will be subjected to statisticalanalysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
- 1)Age limit 25 to 60 years.
- 2)Patient with chronic periodontitis with a probing pocket depth ≥5 mm 3)Patients who are systemically healthy are included.
- 4)Atleast a minimum of 20 Permanent natural teeth should be present.
- 1)Patients with ongoing antibiotic therapy.
- 2)Pregnancy, lactating and smoking.
- 3)Patients undergone surgical or nonsurgical therapy with in 6months prior the study.
- 4)Patients who are deemed to be uncooperative.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: RAL (Relative attachment level) gain. baseline , 3 months secondary outcome variable will be PI, GI ,BOP and probing depth baseline , 3 months To test the hypothesis of adjunctive probiotics and photo dynamic therapy being able to improve non surgical periodontal therapy. baseline , 3 months
- Secondary Outcome Measures
Name Time Method Gingival index, Bleeding index, Plaque index Baseline, 3 months
Trial Locations
- Locations (1)
Department of periodontiology
🇮🇳Nellore, ANDHRA PRADESH, India
Department of periodontiology🇮🇳Nellore, ANDHRA PRADESH, IndiaudhayabhanuPrincipal investigator8074685129udayabhanuvelampalli@gmail.com