Periodontal and Endodontic Lesion Clinical Trial
Official title:
Effects of Chlorhexidine-Metronidazole Combination as an Intracanal Medicament on Periodontal Healing in Concurrent Endodontic Periodontal Lesions With Communication: A Randomized Controlled Clinical Study
Considering the beneficiary properties of both Chlorhexidine (CHX) and Metronidazole (MTZ) such as property of substantivity and diffusion of these drugs on the external surfaces through the anatomical communication channels in between the root canals and periodontium, may be utilized as an alternative approach for the delivery of drug ( intracanal medicament) in the deep periodontal pockets in concurrent endodontic- periodontic lesion with communication lesions. Thus the aim of study is to conduct a prospective randomized controlled clinical trial to evaluate and compare the effects of CHX-MTZ combination with chlorhexidine alone as an intracanal medicament on periodontal healing in concurrent endodontic- periodontic lesion with communication.
INTRODUCTION
The pulp tissue within the tooth and surrounding periodontium are interrelated to each other
due to structural, functional and microbiological similarities. Cross infection of bacterial
colonies take place in between these sites through dentinal tubules, apical foramen, lateral
and accessory canals.Concurrent endodontic- periodontic lesions are those lesions where both
endodontic and periodontal diseases occurring at same time in relation to single tooth.
Endodontic infection present in tooth is responsible for more bone loss, attachment loss and
results in impaired healing of periodontium and vice versa.
Complete elimination of microorganisms from infected root canal is very challenging and
complicated task. It has been reported that bacteria may survive within the root canal even
after chemomechanical preparation, these remaining bacteria again multiply within the root
canal. So, intracanal medicament is used as an adjunct to mechanical preparation in
disinfection of root canal system.
Chlorhexidine (CHX) is widely used as an intracanal medicament because of its high
antimicrobial action, against gram positive and gram negative bacteria.
Antibacterial substantivity of CHX is significantly higher than other medicaments. Various
microbiological studies found the reduction in bacterial adherence, lager zones of microbial
inhibition after application of CHX as an intracanal medicament. Raheja et al described that
2% CHX gel as an intracanal medicament provide substantive antibacterial activity for
sufficiently long periods of time and helps in better healing of endodontic periodontal
lesions without communication in their clinical study. Although, CHX is very effective as an
intracanal medicament, but can't be used as an final irrigant due to it allergic,
hypersensitive reaction, precipitation formation with sodium hypochlorite, EDTA, saline and
ethanol and its inability to dissolve necrotic tissue.
In endodontic and periodontal treatment, antibiotics are valuable adjunctive for management
of bacterial infections. Local application of antibiotics is considered more effective than
systemic administration because of potential risk of adverse effects associated with
systemic application.Metronidazole(MTZ) is nitroimidazole compound having broad
antibacterial spectrum of bactericidal action mainly against anaerobic microorganisms. MTZ
is given along with ciprofloxacin and minocycline as a combination in 3M antibiotic paste in
the form of intracanal medicament. Kargul et al in a clinical study showed that there was no
abscess formation and pathologic mobility when metronidazole is used as an intracanal
medicament.Observations based on in vitro study showed that MTZ-CHX combination was better
than calcium hydroxide as an intracanal medicament against E.faecalis.
Keeping in mind the above observations and considering the beneficiary properties of both
CHX and MTZ such as property of substantivity and diffusion of these drugs on the external
surfaces through the anatomical communication channels in between the root canals and
periodontium, may be utilized as an alternative approach for the delivery of drug (
intracanal medicament) in the deep periodontal pockets in these lesions. Thus the aim of
study is to conduct a prospective randomized controlled clinical trial to evaluate and
compare the effects of CHX-MTZ combination with chlorhexidine alone as an intracanal
medicament on periodontal healing in concurrent endodontic- periodontic lesion with
communication.
MATERIAL AND METHOD
This study will be conducted in Department of Periodontics and Oral Implantology in
collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate
Institute of Dental Sciences (PGIDS), Rohtak. The study protocol is according to the ethical
standards of Helinski declaration 1975 as revised in 2013.
STUDY POPULATION
Patients will be recruited from regular outpatient department of the periodontics,
endodontics and oral medicine PGIDS, Rohtak. The study will be conducted as follows:
Interventional study: This randomized controlled clinical trial will include minimum 36
patients which will be further divided into two groups.
Test Group (n≈ 18)
Treatment involves endodontic treatment using intracanal medicament (chlorhexidine
metronidazole combination) along with open flap debridement.
Positive Control Group (n≈ 18)
Treatment involves endodontic treatment using chlorhexidine alone as an intracanal
medicament along with surgical periodontal therapy in form of open flap debridement.
METHODOLOGY
Patients will be randomly allocated to control and test groups. The study will be conducted
as follows:
1. Presurgical therapy: which will be including
- Oral hygiene instructions and patient motivation
- Full mouth supragingival and subgingival scaling and root planning with ultrasonic
scaler (EMS Piezon 250, Switzerland), hand scaler and curettes (Hu-Friedy) will be
completed in two sessions.
- Root canal therapy will be initiated in both the groups.
- In Test group- Metronidazole-chlorhexidine combination (metronidazole-15mg,
chlorhexidine gluconate-0.5%w/w)as an intracanal medicament and in positive
control group 2% chlorhexidine gel will be placed in root canals. In both groups,
total duration for medicament placement will be of 4 weeks.
2. Surgical therapy : After 2 weeks of intracanal medicament placement in both test group
and in control group, periodontal surgical procedure in the form of open flap
debridement will be performed in both groups.
3. At the time of periodontal surgical procedure, intracanal medicament will be replaced
with fresh one and will be remained in the root canals further for 2 weeks (medicament
placed for total duration of 4 weeks), after that obturation will be done in both
groups.
A probing stent will be fabricated for every patient irrespective of the group, relative to
which attachment level, pocket probing depth will be measured.
CLINICAL PARAMETERS
1. Full mouth indices to be recorded at baseline
- Plaque index(PI)
- Gingival index(GI)
- Bleeding on probing(BOP)
- Probing Pocket depth(PPD)
- Clinical attachment loss(CAL)
2. Site specific indices
- Plaque index(PI)
- Gingival index(GI)
- Relative Probing Pocket depth(RPPD)
- Relative Attachment Loss (RAL)
- Bleeding on probing (BOP)
- Tooth mobility
- Relative Gingival Marginal Level (RGML)
Using UNC 15 periodontal probe at 6 sites (mesiobuccal, distobuccal, mesiolingual,
distolingual, and median points at buccal and at lingual aspects) per tooth except 3 rd
molars for PPD, BOP, GML and CAL while 4 surfaces (mesial, distal, median points at buccal
and lingual aspect) will be measured for PI, GI.
Customized bite blocks and parallel angle technique will be used to obtain radiographs.
Clinical parameters will be recorded at baseline, 2 weeks of endodontic treatment and at 3
months, 6 months of periodontal surgery.
PERIODONTAL NON SURGICAL PROCEDURE
This involves supragingival and subgingival scaling and root planing to be performed with
ultrasonic scaler, hand scaler and curette and will be completed in minimum two sessions
along with patient education and motivation.
ENDODONTIC PROCEDURE
After achieving local anaesthesia, access opening will be made with the help of round bur.
Then the root canal will be thoroughly debride followed by copious irrigation and
subsequently prepared with the help of endo files. After preparation of the canal,
chlorhexidine- metronidazole combination as an intracanal medicament will be placed in test
group, chlorhexidine medicament in positive control group and access cavity will be sealed
with suitable sealer and medicament left inside for the above mentioned time period.
Obturation will be performed with gutta percha and zinc oxide eugenol based sealer.
PERIODONTAL SURGICAL PROCEDURE
After administration of local anaesthesia, buccal and lingual/palatal intracrevicular
incision will be made and mucoperiosteal flaps will be reflected including at least one
tooth ahead and another behind the tooth. Meticulous defect debridement and root planing
will be carried out using area specific curettes and scalers to remove all the granulation
tissue. After instrumentation, the root surfaces will be washed with saline solution in
attempt to remove any remaining detached fragments from the defect and surgical field. After
debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non
absorbable black silk surgical suture. The surgical area will be protected and covered with
periodontal dressing and post operative instructions will be given.
POST OPERATIVE CARE
- Suitable antibiotics and analgesics will be prescribed for 5 days.
- Periodontal dressing and sutures will be removed after 1 week.
- Instructions will be given for gentle brushing with soft brush and reinstructed for
proper oral hygiene postoperatively and will be examined weekly for up to 1 month after
surgery and again at 3 and 6 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03230344 -
Periodontal Surgery With Early vs Delayed Endodontic Treatment in Endo-Perio Lesions Without Communication
|
N/A |