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Attachment LossNCT02630745

Immediate Verses Delayed Surgical Periodontal Therapy After Endodontic Treatment in Endo Perio Lesion With Communication

A study testing Immediate periodontal surgery and Delayed periodontal surgery in people with Attachment Loss and Tooth,Non Vital, run by Postgraduate Institute of Dental Sciences Rohtak.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Attachment Loss, Tooth,Non Vital
What is being tested?
Immediate periodontal surgery and Delayed periodontal surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jun 2015to Oct 2016
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Inclusion Criteria: Patients of age 18 years and above with a clinical and radiographic diagnosis of combined endodontic periodontal lesion and having generalized chronic periodontitis with at least one non vital tooth having apical radiolucency with communication.

  • Wide base pocket, deep pocket depth
  • Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
  • Radiographic periapical alveolar bone destruction with apical communication

Exclusion Criteria:• Systemic illness known to affect the periodontium or outcome of periodontal therapy.

  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Pregnant or lactating mothers.
  • Smokers and tobacco chewers.
  • Grade 3 mobile teeth.
  • Unrestorable tooth.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • Previously root canal filled.
  • History of recent periodontal treatment within 6 months prior to study.

About this study

Official title: Evaluation of the Effect of Immediate and Delayed Surgical Periodontal Therapy After Non-surgical Endodontic Treatment on Periodontal Healing in Concurrent Endodontic Periodontal Lesion With Communication-A Randomized Clinical Trial"

The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication.

Read the detailed description

Observations based upon review articles and case reports has suggested, if the root canal system is infected, endodontic treatment should be commenced prior to any periodontal therapy in order to remove the intra canal infection before any cementum is removed in case of concurrent endodontic-periodontic lesions without communication. This avoids several complications and provides a more favourable environment for periodontal repair. Treatment results of endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment should be considered. But review articles states that teeth that have concurrent endodontic and periodontal diseases that communicate with each other will require comprehensive treatment with both endodontic and periodontal management. Ideally both infections should be removed before the root canal filling and any final restorations are provided. Completion of the root canal filling should be delayed until the periodontal prognosis has been reassessed and determined following initial, and often further, periodontal treatment. Though Infected root canal systems and periodontal pockets have similar microbiological flora, there are more microbes and more species of spirochetes in periodontal pockets than in infected root canal systems, and the microflora in infected root canals of teeth that have concurrent endodontic and periodontal diseases is more complex than in teeth with infection confined to the periapical region. So the outcome of endodontic treatment may be affected if the root canal filling is placed while there is still a periodontal infection present that communicates with the root canal system since cross-seeding through the apical or lateral foramina is possible. An In-vitro study on human extracted teeth states that despite thorough cleaning and disinfection of the root canal system during endodontic treatment, bacteria from the periodontal lesion may re-invade the root canal system since root canal fillings do not seal canals completely.

All the above findings are based on microbiological,histological,case-reports,retrospective and in-vitro studies.The timing of periodontal treatment in concurrent endodontic -periodontal lesions with communication still remains a issue of debate.No prospective human clinical trial(randomized) has been conducted till date to ascertain whether surgical periodontal treatment should be given immediately after completion of non-surgical endodontic treatment or 2-3 months after completion of non-surgical endodontic treatment.

Thus the aim of our study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment for the management of concurrent endodontic -periodontal lesion with communication.

MATERIAL AND METHOD This randomized clinical trial 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, Rohtak.

STUDY POPULATION Patients were recruited from regular out patient department of the department of periodontics and oral implantology,department of conservative dentistry and endodontics and department of oral medicine, diagnosis and radiology. The study will be conducted as follows:-

  1. Immediate surgery group Treatment involves surgical periodontal therapy in form of open flap debridement immediately after non-surgical endodontic treatment.
  2. Delayed surgery group Treatment involves surgical periodontal therapy in form of open flap debridement 3 months after completion of non-surgical endodontic treatment. INCLUSION CRITERIA Patients of age 18 years and above with a clinical and radiographic diagnosis of combined endodontic periodontal lesion and having generalized chronic periodontitis with at least one non vital tooth having apical radiolucency with communication.
  • Wide base pocket, deep pocket depth
  • Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
  • Radiographic periapical alveolar bone destruction with apical communication
  • Patients having generalized chronic periodontitis [≥2 interproximal sites with clinical attachment level (CAL) ≥ 4mm,not on same tooth(moderate) or ≥2 interproximal sites with clinical attachment level (CAL)≥6mm ,not on same tooth (severe)]26

EXCLUSION CRITERIA

  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Pregnant or lactating mothers.
  • Smokers and tobacco chewers.
  • Grade 3 mobile teeth.
  • Unrestorable tooth.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • Previously root canal filled.
  • History of recent periodontal treatment within 6 months prior to study.

Prior informed consent will be taken from each patient after explaining the procedure in patient's language along with risk and benefits involved.

METHODOLOGY Patients were randomly allocated to group1 and group 2. The study will be conducted as follows:-

  1. Presurgical therapy:- which will be including
  • Oral hygiene instructions
  • Full mouth supragingival and subgingival scaling and root planning with ultrasonic scaler, hand scaler and curettes.
  • Conventional root canal therapy will be initiated in both the groups before definite periodontal surgical therapy.
  1. Surgical therapy:- In group 1 periodontal surgical procedure in the form of open flap debridement will be performed immediately after obturation of the root canal system In group 2 periodontal surgical procedure in the form of open flap debridement will be performed 3 months after obturation of the root canal system Prior to surgery, a probing stent will be fabricated for every patient,relative to which attachment loss will be measured.

CLINICAL PARAMETERS

  1. Full mouth indices to be recorded at baseline
  • Bleeding on probing
  • Probing Pocket depth
  • Attachment loss
  1. Site specific indices
  • Plaque index
  • Gingival index
  • Relative Probing Pocket depth
  • Relative attachment loss
  • Bleeding on probing
  • Tooth mobility
  • Relative gingival marginal level Using periodontal probe at 6 sites (mesial, distal, median points at buccal and lingual aspects) per tooth.

Customized bite blocks and parallel angle technique will be used to obtain radiographs Clinical parameters will be recorded at baseline, 3 months and 6 months for Group 1(immediate surgery) Clinical parameters will be recorded at baseline, 3 months, 6 months and 9 months for Group 2(delayed surgery) PERIODONTAL PROCEDURE This involves supragingival and subgingival scaling and root planning to be performed with ultrasonic scaler, hand scaler and curette and will be completed in minimum two sessions.

CONVENTIONAL ENDODONTIC PROCEDURE After achieving local anaesthesia, access opening will be made with the help of round bur. Then the root canal will be thoroughly debrided followed by copious irrigation and subsequently prepared with the help of endo files. After preparation of the canal, calcium hydroxide intracanal medicament will be placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer. 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 atleast one tooth ahead and another behind the tooth. Meticulous defect debridement and root planning will be carried out using area specific curettes and scalers with special effort 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.

Processing of Data Data recorded will be processed by standard statistical analysis.

Being tested
Immediate periodontal surgery, Delayed periodontal surgery
Keywords
endodontic treatment, open flap debridement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate periodontal surgeryProcedure or surgery

    Treatment involves immediate surgical periodontal therapy in form of open flap debridement after non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in concurrent endodontic periodontal lesions with communication .

  • Delayed periodontal surgeryProcedure or surgery

    Treatment involves surgical periodontal therapy after 3 months of non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in the form of open flap debridement in concurrent endodontic periodontal lesions with communication .

Study groups in NCT02630745
Study groupRoleWhat they receive
Immediate periodontal surgery (Group 1)Active comparatorperiodontal surgical procedure in the form of open flap debridement will be performed immediately( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) after obturation of the root canal system( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer).
Receives: Procedure: Immediate periodontal surgery
Delayed periodontal surgery (Group 2)Active comparatorperiodontal surgical procedure in the form of open flap debridement( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) will be performed 3 months after obturation of the root canal system ( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer).
Receives: Procedure: Delayed periodontal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Attachment Loss

    measurement done by periodontal probe with stents

    Measured: 6 months in group 1, 9 months in group 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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
Double blind
Who is masked
Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630745
Sponsor's protocol ID
Perio 2
Status last verified
Dec 2015
First submitted
8 Dec 2015
Last updated
26 Sep 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Immediate periodontal surgery and Delayed periodontal surgery in people with Attachment Loss and Tooth,Non Vital, run by Postgraduate Institute of Dental Sciences Rohtak.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Relative Attachment Loss (time frame: 6 months in group 1, 9 months in group 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Sep 2017.

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