Clinical Trials Logo

Clinical Trial Summary

Background and objective(s): Periodontitis is initiated by a dysbiotic host-microbe relationship. Standard periodontal treatment involves oral hygiene education, mechanical debridement and periodic follow-ups with the aims of pocket closure and maintaining a symbiotic microbial community. Nonetheless, this therapy alone may fail due to the limitations of mechanical instrumentation. The use of antimicrobial in combination to subgingival debridement has been proposed for initial and recurrent periodontitis to enhance the effectiveness of mechanical instrumentation. Antimicrobial peptide (AMP) comprised of a wide range of peptide, was found naturally in various life forms or manufactured as a synthetic compound. This study was conducted to evaluate the use of AMP as an adjunct to non-surgical periodontal treatment in terms of clinical and microbiological outcomes. Hypothesis • There are changes in clinical periodontal parameters and subgingival microbial profile following treatment with locally delivered synthetic AMP.

Clinical Trial Description

study design: This was a split-mouth randomised pilot study of a 3-months follow-up. Sample size calculation: The sample size was calculated using G*Power software version (Franz Faul, Universitat Kiel, Germany). Estimation of sample size was based on the mean and standard deviation of CAL between the test and control group of previous publication (Singh et al., 2018). Four samples in each group (test and control) were required to achieve 80% power at a significant level of 5%. Randomisation: The random allocation sequence was generated by another person who was not directly involved in the study using a Research Randomizer tools ( Periodontal sites of each patient were randomised at a split mouth level (left or right halves of the dentition) to one of the two treatment groups. Allocated treatments were inserted into an opaque envelop. Treatment allocation was concealed from the clinician and only revealed once subgingival debridement was completed. intervention: At baseline, clinical measurement was recorded and target sites (sites with PPD ≥6mm) were identified. subgingival plaque were collected at target sites. The same clinician performed full mouth scaling and subgingival debridement, coupled with standardised oral hygiene instruction for all subjects. Upon the completion of treatment, second clinician applied the treatments according to the randomisation. - Test group: Subgingival instrumentation followed by Antimcrobial peptide gel (AMP) application in all target sites. - Control group: Subgingival instrumentation and normal saline irrigation in all target sites. Test and control intervention will be repeated for another 2 applications at an interval of 3 days. Subjects were re-examined and plaque sampling will be repeated at 6 weeks and 12 weeks. statistical analysis: Clinical parameters were reported as mean and standard deviation. P-value <0.05 was considered statistically significant. intergroup and intragroup comparison of mean bleeding score, pocket depth, clinical attachment level will be conducted using SPSS software. For the metagenomic data, alpha and beta diversity were computed using QIIME 2. The difference in the relative abundance of individual genus over time will be analysed. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05125718
Study type Interventional
Source University of Malaya
Status Completed
Phase Early Phase 1
Start date January 1, 2021
Completion date April 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT04712630 - Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft N/A
Recruiting NCT04964167 - Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis Early Phase 1
Recruiting NCT03997552 - NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration N/A
Recruiting NCT03790605 - A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis Phase 3
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
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Completed NCT02835898 - Epigenetics and Periodontal Treatment Phase 1
Completed NCT02447510 - Growth Factors Release of PRF and PRGF Phase 3
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Completed NCT02124655 - Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. Phase 4
Active, not recruiting NCT02135952 - Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis Phase 4
Completed NCT04527913 - Interdental Plaque Reduction and Periodontitis N/A
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Recruiting NCT02131922 - Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control N/A
Completed NCT00226148 - Immediate Implant Placement in the Molar Regions Phase 0
Completed NCT00327561 - Effect of Intensive Periodontal Therapy on Vascular Function Phase 3