Chronic PeriodontitisNCT02208739
Effect of Nonsurgical Periodontal Therapy Verses Oral Hygiene Instructions on Patients With Chronic Periodontitis
A study testing Nonsurgical periodontal therapy and Oral hygiene instructions in people with Chronic Periodontitis, run by University of Malaya at 1 site in Malaysia.
Trial summary
Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory disease of the periodontium which results in irreversible destruction of supporting structures of the teeth such as periodontal ligaments, connective tissues, cementum and alveolar bone. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Nonsurgical periodontal therapy and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should have at least 12 teeth present
- Patients with Moderate to Advanced Chronic periodontitis
- Patients with 2 or more interproximal sites (not on same tooth) with probing pocket depths of 5mm or more and 2 or more interproximal sites (not on same tooth)of probing attachment loss of 4mm or more which bled on probing.
Who cannot join
- Patients who had history of systemic antibiotic usage over the previous 4 months
- Patients who were pregnant
- Patients who had received non-surgical periodontal treatment within the past 6 months
- Patients who had received surgical periodontal treatment within the past 12 months
- Patients who were smokers
- Patients with a history of stroke or an acute cardiovascular event over the previous 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nonsurgical Periodontal Therapy Verses Oral Hygiene Instructions on Clinical Parameters as Well as Immunological and Microbial Profile of Patients With Chronic Periodontitis
Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory disease of the periodontium which results in irreversible destruction of supporting structures of the teeth such as periodontal ligaments, connective tissues, cementum and alveolar bone. More than 700 species of bacteria are estimated to be found in the sub-gingival dental biofilm in which periodontopathogens are found to be responsible in initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for the systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide (LPS) from gram-negative bacteria with host cells initiates the secretion of cytokines and the expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar bone and connective tissues supporting the teeth.
In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which includes oral hygiene instruction (OHI), scaling and root planing, is administered to improve clinical parameters as well as controlling the bacterial count responsible in initiating the disease and the resultant inflammatory response. Success of the treatment can be analyzed when the clinical parameters, counts of the microbes is reduced and inflammatory response is controlled. Studies which have evaluated the microbiological and immunological response following NSPT clearly demonstrates an improvement in clinical parameters, reduction in inflammatory mediators present as well as a decrease in microbial count.
OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing microbial plaque, thus, preventing periodontal diseases such as gingivitis and periodontitis. Studies have evaluated the role of OHI on clinical and immunological parameters and microbiological profiles of periodontal maintenance subjects, while none of them evaluated its role alone in the management of chronic periodontitis subjects. Therefore, the purpose of the following investigation was to compare the changes in the clinical parameters, inflammatory mediators as well as level and frequency of detection of periodontopathogens that take place after 3-months of NSPT versus OHI and to evaluate if clinical parameters have an effect on these inflammatory mediators and microbiological changes.
Read the detailed description
Subjects with moderate to advanced chronic periodontitis were selected for this longitudinal randomized clinical trial. Ethical clearance for the study was granted by the Medical Ethics Committee, Faculty of Dentistry, University of Malaya [Medical Ethics Committee Number: DF PE1002/0045(P)]. The study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000. The CONSORT guidelines for clinical trials were followed.
Out of 112 screened patients 56 patients fulfilled the inclusion and exclusion criteria. Inclusion criteria were minimum of 12 teeth present with pocket of 5mm or more and probing attachment loss of 4mm or more in at least 2 different quadrants which bled on probing. Exclusion criteria included history of cardiovascular problems, pregnancy, smokers, and subjects receiving antibiotics in past 4 months or NSPT in past 6 months. Recruited patients were treated at the Periodontology clinic, Faculty of Dentistry, University of Malaya. Using Cohen's d formula it was calculated that at least 26 patients would be needed per treatment group to detect this difference with 80% power.
Prior to baseline examination, patients were assigned in the NSPT and OHI group using block randomization. Patients in NSPT group received OHI, scaling and root planing followed by 0.12% Chlorhexidine mouth rinses while patients in OHI group received OHI only. At each month recall visit, participants in both groups were reviewed and motivated. Professional prophylaxis was only received by NSPT group. Two calibrated examiners (RPCR and WNAWA) performed all treatment on the patients. Probing pocket depth ( PPD), probing attachment loss (PAL), gingival bleeding index (BI) and visible plaque index (PI) were determined on all present teeth except third molars at baseline and 3 months after therapy. For PI and BI, 4 sites were measured (mesial, distal, buccal, lingual) and for PPD and PAL 6 sites were recorded (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual). Utilizing Kappa statistics, good agreements (>0.8) were obtained for intra and inter operator reproducibility of all recorded clinical parameters.
Identification of subgingival microbiota using quantitative polymerase chain reaction technique.
Sub-gingival plaque scraping samples were obtained at baseline and 3-months post therapy with sterile curettes from the deepest sites at each quadrant and were pooled together for each subject. Prior to sampling, isolation was maintained with cotton rolls and supra-gingival plaque was removed using cotton pellets. Plaque scrapings were re-suspended in 1.5 ml of Phosphate Buffered Saline and stored at -80⁰C freezer prior to DNA extraction. 100µl of plaque sample was used for automated DNA extraction in the lab using the Qiacube machine (Qiagen®, Biotechnology, Netherlands). The tubes containing the plaque samples were centrifuged at a speed of 5,000 × g for 10 minutes on a tabletop centrifuge machine to obtain the pellet. The pellet was then used for automated DNA extraction with the Qiacube machine. 100µl of eluted DNA was stored in -20⁰C for bacterial detection using quantitative polymerase chain reaction (Applied Biosystem, USA).
Reference bacterial strains used in this study were P.gingivalis (W83), A.actinomycetemcomitans (NCTC9710), P.intermedia (ATCC25611) and T.forsythia (CCUG 21028AT). All the bacterial strains were grown as recommended by American Type Culture Collection (ATCC). After the growth of bacteria till late exponential phase they were washed with sterile distilled water and DNA extraction was carried out using the same protocol as for plaque samples.
The concentration and purity of extracted DNA was determined using spectrophotometer machine (Nanodrop 2000, Thermo scientific, USA). DNA concentration from both plaque samples and reference strain were calculated and recorded accordingly. The extracted DNAs were stored in -20⁰C until the initiation of quantitative polymerase chain reaction procedure.
The protocol given by Boutaga et al., (2005) was followed for quantitative polymerase chain reaction . Primers and probes selected for this study are shown in Table 1. A total reaction mixture of 20ul was used for amplification, which contains 2ul of template DNA from plaque sample/reference strain,10 ul of 2 x TaqMan fast advanced master mix (Applied biosystems, USA), 1ul of 20x gene expression assay and 7ul nuclease free water. All the components of reaction mixture except for DNA sample were added in 1.5ml micro centrifuge tube. The tube was vortexed and than centrifuged to eliminate air bubbles. Mixture was transferred to 96-well plate with addition of 2ul DNA sample. The Plate was then covered with optical adhesive and centrifuged again to make sure air bubbles are eliminated. The cycling conditions used were as follows: 50oc for 2min and 95oc for 10min followed by 45 cycles at 95oc for 15s and 60oc for 1min.
Dilutions of known amounts of reference strains of DNA were used to generate standard curves with correlation coefficient (R2: 0.99). For quantification/copy number determination, the results from unknown samples were projected on the standard curves obtained from the pure cultures using the formula: Quantity DNA=10(ct-b)/m.
Determination of Interleukin-1, Interleukin-6, Adiponectin and Tumour Necrosis Factor-alpha level in Serum.
All reagents were allowed to reach room temperature before use and were gently mixed prior to the experiments. Number of 8-well strips needed for the assay was determined. 100 ul of the Standard Diluent Buffer were added to zero wells and 1 well was reserved for chromogen blank. 100 ul of standards, samples and controls were added to the appropriate microtiter wells. 50 ul of biotinylated anti-Interleukin-6 (Biotin Conjugate) solution were pipetted into each well except the chromagen blank and then gently tapped on the side of the plate to mix. Next, plates were covered with plate covers and incubated for 2 hours at room temperature. Solutions were thoroughly aspirated from wells and the liquid discarded. The wells were washed 4 times. 100 ul streptavidin-histidine-rich protein working solution were added to each well except the chromogen blank. Again, the plates were covered with the plate covers and incubated for 30 minutes at room temperature. Solution from wells was thoroughly aspirated and the liquid discarded. The wells were washed 4 times. 100ul of Stabilized Chromogen was added to each well. The plates were incubated for 30 minutes at room temperature in the dark. 100 ul of stop solution was added to each well and then gently tapped on the side of the plate to mix. The absorbance of each well was read at 450 nm having blanked the plate reader against a chromogen blank composed of 100 ul each of Stabilized Chromogen and Stop Solution. The absorbance of the standards against the standard concentration was then plotted on graph paper.
- Conditions
- Chronic Periodontitis
- Being tested
- Nonsurgical periodontal therapy, Oral hygiene instructions
- Keywords
- Chronic periodontitis, periodontal pathogens, inflammatory mediators, Non surgical periodontal therapy, Oral hygiene instructions, Polymerase chain reaction, Elisa
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical periodontal therapyProcedure or surgery
All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique. Full mouth debridement, which consisted of scaling and root planing, was done in a single visit for all subjects using an ultrasonic scaler and gracey curettes. Additionally, all patients were given a 0.12% Chlorhexidine mouthrinse (Hexipro®). They were instructed to rinse three times a day using 15ml each time for a period of 14 days commencing immediately after completion of full mouth debridement. Thereafter at each recall visit, all participants were re-motivated and professional prophylaxis was performed.
Oral hygiene instructionsProcedure or surgery
All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique.
| Study group | Role | What they receive |
|---|---|---|
| Nonsurgical periodontal therapy | Experimental | Nonsurgical periodontal therapy was given to all patients at baseline Receives: Procedure: Nonsurgical periodontal therapy |
| Oral hygiene instructions | Active comparator | Oral hygiene instructions were given to all patients at baseline Receives: Procedure: Nonsurgical periodontal therapy; Procedure: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of NSPT vs OHI on probing pocket depth of subjects with chronic periodontitis
Outcome measurements assessed are probing pocket depth
Measured: Baseline to 3 months
Secondary outcomes (7)
Effect of NSPT vs OHI on microbiological parameters of subjects with chronic periodontitis
Changes in subgingival microbiota were assessed as changes in frequency of detection and microbial count of A.actinomycetemcomitans, T.forsythia, P.gingivalis and P.intermedia from baseline to 3 months post therapy.
Measured: Baseline to 3 months
Effect of NSPT vs OHI on immunological parameters of subjects with chronic periodontitis
Changes in immunological parameters were assessed as changes in levels of high-sensitivity C-reactive protein , Interleukin-1, Interleukin-6. Tumour Necrosis Factor alpha, adiponectin and resistin from baseline to 3 months post therapy.
Measured: Baseline to 3 months
Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis
Changes in oral health related quality of life from baseline to 3 months post therapy in both treatment groups.
Measured: Baseline to 3 months
Effect of NSPT vs OHI on plaque index of subjects with chronic periodontitis
Outcome measurements assessed are Plaque index
Measured: Baseline to 3 months
Effect of NSPT vs OHI on gingival bleeding index of subjects with chronic periodontitis
Outcome measurements assessed are Gingival bleeding index
Measured: Baseline to 3 months
Effect of NSPT vs OHI on clinical attachment level of subjects with chronic periodontitis
Outcome measurements assessed are clinical attachment levels
Measured: Baseline to 3 months
Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis
Outcome measurements assessed are oral health related quality of life
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rathna D Vaithilingam, MClinDent, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208739
- Sponsor's protocol ID
- PPPC-C2
- Status last verified
- Jul 2015
- First submitted
- 30 Jul 2014
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doungudomdacha S, Rawlinson A, Walsh TF, Douglas CW. Effect of non-surgical periodontal treatment on clinical parameters and the numbers of Porphyromonas gingivalis, Prevotella intermedia and Actinobacillus actinomycetemcomitans at adult periodontitis sites. J Clin Periodontol. 2001 May;28(5):437-45. doi: 10.1034/j.1600-051x.2001.028005437.x.
PubMed 11350507Knofler GU, Purschwitz RE, Eick S, Pfister W, Roedel M, Jentsch HF. Microbiologic findings 1 year after partial- and full-mouth scaling in the treatment of moderate chronic periodontitis. Quintessence Int. 2011 Oct;42(9):e107-17.
PubMed 21909493
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nonsurgical Periodontal Therapy Verses Oral Hygiene Instructions on Clinical Parameters as Well as Immunological and Microbial Profile of Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT02208739
- Acronym / sponsor ID
- PPPC-C2
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic periodontitis, periodontal pathogens, inflammatory mediators, Non surgical periodontal therapy, Oral hygiene instructions, Polymerase chain reaction, Elisa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory disease of the periodontium which results in irreversible destruction of supporting structures of the teeth such as periodontal ligaments, connective tissues, cementum and alveolar bone. More than 700 species of bacteria are estimated to be found in the sub-gingival dental biofilm in which periodontopathogens are found to be responsible in initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for the systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide (LPS) from gram-negative bacteria with host cells initiates the secretion of cytokines and the expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar bone and connective tissues supporting the teeth.
In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which includes oral hygiene instruction (OHI), scaling and root planing, is administered to improve clinical parameters as well as controlling the bacterial count responsible in initiating the disease and the resultant inflammatory response. Success of the treatment can be analyzed when the clinical parameters, counts of the microbes is reduced and inflammatory response is controlled. Studies which have evaluated the microbiological and immunological response following NSPT clearly demonstrates an improvement in clinical parameters, reduction in inflammatory mediators present as well as a decrease in microbial count.
OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing microbial plaque, thus, preventing periodontal diseases such as gingivitis and periodontitis. Studies have evaluated the role of OHI on clinical and immunological parameters and microbiological profiles of periodontal maintenance subjects, while none of them evaluated its role alone in the management of chronic periodontitis subjects. Therefore, the purpose of the following investigation was to compare the changes in the clinical parameters, inflammatory mediators as well as level and frequency of detection of periodontopathogens that take place after 3-months of NSPT versus OHI and to evaluate if clinical parameters have an effect on these inflammatory mediators and microbiological changes.
Detailed description
Subjects with moderate to advanced chronic periodontitis were selected for this longitudinal randomized clinical trial. Ethical clearance for the study was granted by the Medical Ethics Committee, Faculty of Dentistry, University of Malaya [Medical Ethics Committee Number: DF PE1002/0045(P)]. The study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000. The CONSORT guidelines for clinical trials were followed.
Out of 112 screened patients 56 patients fulfilled the inclusion and exclusion criteria. Inclusion criteria were minimum of 12 teeth present with pocket of 5mm or more and probing attachment loss of 4mm or more in at least 2 different quadrants which bled on probing. Exclusion criteria included history of cardiovascular problems, pregnancy, smokers, and subjects receiving antibiotics in past 4 months or NSPT in past 6 months. Recruited patients were treated at the Periodontology clinic, Faculty of Dentistry, University of Malaya. Using Cohen's d formula it was calculated that at least 26 patients would be needed per treatment group to detect this difference with 80% power.
Prior to baseline examination, patients were assigned in the NSPT and OHI group using block randomization. Patients in NSPT group received OHI, scaling and root planing followed by 0.12% Chlorhexidine mouth rinses while patients in OHI group received OHI only. At each month recall visit, participants in both groups were reviewed and motivated. Professional prophylaxis was only received by NSPT group. Two calibrated examiners (RPCR and WNAWA) performed all treatment on the patients. Probing pocket depth ( PPD), probing attachment loss (PAL), gingival bleeding index (BI) and visible plaque index (PI) were determined on all present teeth except third molars at baseline and 3 months after therapy. For PI and BI, 4 sites were measured (mesial, distal, buccal, lingual) and for PPD and PAL 6 sites were recorded (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual). Utilizing Kappa statistics, good agreements (>0.8) were obtained for intra and inter operator reproducibility of all recorded clinical parameters.
Identification of subgingival microbiota using quantitative polymerase chain reaction technique.
Sub-gingival plaque scraping samples were obtained at baseline and 3-months post therapy with sterile curettes from the deepest sites at each quadrant and were pooled together for each subject. Prior to sampling, isolation was maintained with cotton rolls and supra-gingival plaque was removed using cotton pellets. Plaque scrapings were re-suspended in 1.5 ml of Phosphate Buffered Saline and stored at -80⁰C freezer prior to DNA extraction. 100µl of plaque sample was used for automated DNA extraction in the lab using the Qiacube machine (Qiagen®, Biotechnology, Netherlands). The tubes containing the plaque samples were centrifuged at a speed of 5,000 × g for 10 minutes on a tabletop centrifuge machine to obtain the pellet. The pellet was then used for automated DNA extraction with the Qiacube machine. 100µl of eluted DNA was stored in -20⁰C for bacterial detection using quantitative polymerase chain reaction (Applied Biosystem, USA).
Reference bacterial strains used in this study were P.gingivalis (W83), A.actinomycetemcomitans (NCTC9710), P.intermedia (ATCC25611) and T.forsythia (CCUG 21028AT). All the bacterial strains were grown as recommended by American Type Culture Collection (ATCC). After the growth of bacteria till late exponential phase they were washed with sterile distilled water and DNA extraction was carried out using the same protocol as for plaque samples.
The concentration and purity of extracted DNA was determined using spectrophotometer machine (Nanodrop 2000, Thermo scientific, USA). DNA concentration from both plaque samples and reference strain were calculated and recorded accordingly. The extracted DNAs were stored in -20⁰C until the initiation of quantitative polymerase chain reaction procedure.
The protocol given by Boutaga et al., (2005) was followed for quantitative polymerase chain reaction . Primers and probes selected for this study are shown in Table 1. A total reaction mixture of 20ul was used for amplification, which contains 2ul of template DNA from plaque sample/reference strain,10 ul of 2 x TaqMan fast advanced master mix (Applied biosystems, USA), 1ul of 20x gene expression assay and 7ul nuclease free water. All the components of reaction mixture except for DNA sample were added in 1.5ml micro centrifuge tube. The tube was vortexed and than centrifuged to eliminate air bubbles. Mixture was transferred to 96-well plate with addition of 2ul DNA sample. The Plate was then covered with optical adhesive and centrifuged again to make sure air bubbles are eliminated. The cycling conditions used were as follows: 50oc for 2min and 95oc for 10min followed by 45 cycles at 95oc for 15s and 60oc for 1min.
Dilutions of known amounts of reference strains of DNA were used to generate standard curves with correlation coefficient (R2: 0.99). For quantification/copy number determination, the results from unknown samples were projected on the standard curves obtained from the pure cultures using the formula: Quantity DNA=10(ct-b)/m.
Determination of Interleukin-1, Interleukin-6, Adiponectin and Tumour Necrosis Factor-alpha level in Serum.
All reagents were allowed to reach room temperature before use and were gently mixed prior to the experiments. Number of 8-well strips needed for the assay was determined. 100 ul of the Standard Diluent Buffer were added to zero wells and 1 well was reserved for chromogen blank. 100 ul of standards, samples and controls were added to the appropriate microtiter wells. 50 ul of biotinylated anti-Interleukin-6 (Biotin Conjugate) solution were pipetted into each well except the chromagen blank and then gently tapped on the side of the plate to mix. Next, plates were covered with plate covers and incubated for 2 hours at room temperature. Solutions were thoroughly aspirated from wells and the liquid discarded. The wells were washed 4 times. 100 ul streptavidin-histidine-rich protein working solution were added to each well except the chromogen blank. Again, the plates were covered with the plate covers and incubated for 30 minutes at room temperature. Solution from wells was thoroughly aspirated and the liquid discarded. The wells were washed 4 times. 100ul of Stabilized Chromogen was added to each well. The plates were incubated for 30 minutes at room temperature in the dark. 100 ul of stop solution was added to each well and then gently tapped on the side of the plate to mix. The absorbance of each well was read at 450 nm having blanked the plate reader against a chromogen blank composed of 100 ul each of Stabilized Chromogen and Stop Solution. The absorbance of the standards against the standard concentration was then plotted on graph paper.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonsurgical periodontal therapy | Experimental | Procedure: Nonsurgical periodontal therapyNonsurgical periodontal therapy was given to all patients at baseline |
| Oral hygiene instructions | Active comparator | Procedure: Nonsurgical periodontal therapy, Procedure: Oral hygiene instructionsOral hygiene instructions were given to all patients at baseline |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients should have at least 12 teeth present
- Patients with Moderate to Advanced Chronic periodontitis
- Patients with 2 or more interproximal sites (not on same tooth) with probing pocket depths of 5mm or more and 2 or more interproximal sites (not on same tooth)of probing attachment loss of 4mm or more which bled on probing.
Key exclusion criteria (6 listed)
- Patients who had history of systemic antibiotic usage over the previous 4 months
- Patients who were pregnant
- Patients who had received non-surgical periodontal treatment within the past 6 months
- Patients who had received surgical periodontal treatment within the past 12 months
- Patients who were smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonsurgical periodontal therapyAll patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique. Full mouth debridement, which consisted of scaling and root planing, was done in a single visit for all subjects using an ultrasonic scaler and gracey curettes. Additionally, all patients were given a 0.12% Chlorhexidine mouthrinse (Hexipro®). They were instructed to rinse three times a day using 15ml each time for a period of 14 days commencing immediately after completion of full mouth debridement. Thereafter at each recall visit, all participants were re-motivated and professional prophylaxis was performed. | Procedure or surgery | Nonsurgical periodontal therapy, Oral hygiene instructions |
| Oral hygiene instructionsAll patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique. | Procedure or surgery | Oral hygiene instructions |
Primary outcome
Effect of NSPT vs OHI on probing pocket depth of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Outcome measurements assessed are probing pocket depth
7 secondary outcomes
Effect of NSPT vs OHI on microbiological parameters of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Effect of NSPT vs OHI on immunological parameters of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Effect of NSPT vs OHI on plaque index of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Effect of NSPT vs OHI on gingival bleeding index of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Effect of NSPT vs OHI on clinical attachment level of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Background: PubMed 11350507Doungudomdacha S, Rawlinson A, Walsh TF, Douglas CW. Effect of non-surgical periodontal treatment on clinical parameters and the numbers of Porphyromonas gingivalis, Prevotella intermedia and Actinobacillus actinomycetemcomitans at adult periodontitis sites. J Clin Periodontol. 2001 May;28(5):437-45. doi: 10.1034/j.1600-051x.2001.028005437.x.
- Background: PubMed 21909493Knofler GU, Purschwitz RE, Eick S, Pfister W, Roedel M, Jentsch HF. Microbiologic findings 1 year after partial- and full-mouth scaling in the treatment of moderate chronic periodontitis. Quintessence Int. 2011 Oct;42(9):e107-17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rathna D Vaithilingam, MClinDent principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonsurgical periodontal therapy and Oral hygiene instructions in people with Chronic Periodontitis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of NSPT vs OHI on probing pocket depth of subjects with chronic periodontitis (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02208739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.