Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03284736 |
| Other study ID # |
pragnesh endo |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
September 8, 2017 |
| Last updated |
September 12, 2017 |
| Start date |
October 2016 |
| Est. completion date |
November 2017 |
Study information
| Verified date |
September 2017 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study Title: Effects of Guided Tissue Regeneration on the Healing of Through & Through
Periradicular Lesions - A Randomized Controlled Study
Rationale: Through and through defects found to be difficult to heal without GTR
intervention. Various studies has been done either with graft or without graft but no
randomized controlled trial has been done on resorbable membrane(GTR) in through and through
lesion.
Aim & Objectives: To evaluate the effect of resorbable collagen membrane in the healing of
through & through lesion.
Setting: Study was conducted in Post Graduate Institute Of Dental Sciences, Rohtak in the
department of Conservative Dentistry & Endodontics.
Study Design: Randomized Controlled Trial
Time Frame: March 2016 to October 2017
Population / Participants: Patients of age 16 years (male/female) and above were enrolled in
the study.
Inclusion Criteria: Patients of age 16 years and above, -ve response to vitality test, failed
previous root canal treatment with purulent discharge, failed previous surgery, recurrent
episode of purulent discharge.
Exclusion Criteria: Unrestorable tooth, fractured /perforated roots, serious medical illness,
smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for
antibiotic prophylaxis prior to dental care.
Sample size: 30 patients (15 patients in each group)
Methods: Clinically and radiographically diagnosis of lesion, vitality check by EPT,
preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal
position & pocket depth. Surgical procedures will be carried out under operating microscope
with 8 × 16 magnification by following standardized treatment methods.
Outcome measures: Follow up of patients were carried out at 3, 6, 9 & 12 months and outcome
measures were compared with same method done pre operatively and described as Complete
healing, incomplete healing (scar tissue), uncertain healing, unsatisfactory healing
(failure).
Statistical method: Data will be analyzed with suitable statistics method.
Description:
The research process was carried out in the Department Of Conservative Dentistry and
Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. Patients with through and
through periradicular lesions diagnosed radiographically and clinically were be included in
the study.
INCLUSION CRIETERIA :-
1. Patients of age 16 years and above with a clinical & radiographic diagnosis of through
and through periradicular lesion.
2. Negative response to vitality test with radiographic evidence of periapical
rediolucencies.
3. Failed previous root canal treatment with purulent discharge and radiographic evidence
of periapical pathology.
4. Failed previous surgery with persistent bony lesion.
5. Recurrent episode of purulent discharge and adequate final restoration with no clinical
evidence of coronal leakage.
EXCLUSION CRIETERIA :-
1. Unrestorable tooth
2. Fractured /perforated roots
3. Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life
threatening conditions or requiring antibiotic prophylaxis)
4. Smokers
5. Pregnant females and lactating mothers
6. Grade 3 mobile teeth
7. The need for antibiotic prophylaxis prior to dental care
Baseline parameters --
Endodontic evaluation - Pulp sensibility testing was performed with a combination of heat
test (heated gutta-percha), cold test (Endo-Frost, Coltene Whale dent) and electric pulp test
(Digitestz D626D, Parkell electronics, New York). Teeth not responding to both thermal and
electric test were considered non vital.
Radiographic evaluation - Radiographs with paralleling cone technique was taken at baseline
and at subsequent appointments at standardized exposure parameters (70kvp, 3.5mAs, and 0.2
seconds).
Clinical Periodontal Evaluation - The following clinical parameters were evaluated at
baseline and at subsequent follow up appointments in the test tooth and the contra lateral
normal tooth in the same patient.
1. Bleeding on probing - The presence or absence of bleeding following pocket probing were
recorded at 6 sites per tooth - mesiobuccal, buccal, distobuccal, mesiolingual,
midlingual, distolingual. This assessment was done in full mouth.
2. Probing pocket depth (PPD) - Probing depth was measured as the distance from the
gingival margin to the base of the clinical pocket. The probing depth measurements was
assessed using a calibrated manual periodontal Williams 0 probe. The probe was inserted
with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the
vertical axis of the tooth. Measurements were noted at 6 sites per tooth- mesiobuccal,
midbuccal, distobuccal, mesiolingual, midlingual, distolingual. Measurements will be
rounded to the nearest whole millimeter.
3. Clinical Attachment Level (CAL) - Clinical Attachment Level was measured as the distance
between the base of the clinical pocket and a fixed point on the crown, the
cementoenamel junction (CEJ). Measurements were made at 6 sites per tooth- mesiobuccal,
midbuccal, distobuccal, mesiolingual, midlingual, distolingual using wiliiams 0 probe.
Measurements were rounded to the nearest whole millimeter. The mean CAL over all
examined surfaces were calculated.
4. Gingival marginal level/position from CEJ was measured.Radiographic examination was
performed at 0, 3, 6, 9 and 12 months by using Rinn ( XCP instruments, Elgin, IL )
paralleling technique digitized by using Kodak RVG 6000 ( Kodak Digital Radiographic
System, Pt Husada Intra Care, Banten, Indonesia ).
SAMPLE SIZE
A total number of 15 patients in each group were selected. Sample size was determined by
calculating the difference of success rate between the previous studies of GTR procedures.
1. Test Group: 15 Non vital teeth having through and through periradicular lesion diagnosed
clinically and radiographically first treated with conventional endodontic treatment.
After follow up of one month if no improvement found clinically and radiographically
then apical surgery was carried out using guided tissue regeneration in patients.
2. Control Group: 15 Non vital teeth having through and through periradicular lesion
diagnosed clinically and radiographically first treated with conventional endodontic
treatment. After follow up of one month if no improvement found clinically and
radiographically then apical Surgery was carried out without using guided tissue
regeneration.
RANDOMIZATION
Patients were randomly allocated by computer program [ Random Allocation Software
(http://www.msaghaei.com/Softwares/dnld/RA.zip) ] into two group. Group I=Collagen membrane
group (MG), group II=Control group (CG).
SURGICAL TECHNIQUE:
With the exception of incisions, flap elevation and suturing, all surgical procedures was
performed under operating microscope in an operating room under 8x to 16x magnification.
The full thickness (mucoperiosteal flap) was reflected under aseptic condition by the
following technique
1. Preoperative mouth rinse with 0.2% chlorhexidine mouthwash was used.
2. Local anaesthesia with lidocaine 2% with epinephrine 1:80,000 was achieved.
3. Buccal intrasulcular incision was given up to the alveolar crest including one tooth
mesial to the lesion & two teeth distal to the lesion, using no.15 blade on handle.
4. Mesial and distal vertical releasing incision were given.
5. Full thickness flap was gently reflected towards the apical area by periosteal elevator.
The flap was frequently irrigated with sterile saline to prevent dehydration of
periosteal surface.
6. After complete elevation of the flap, debridement (periradicular curettage -enucleation)
of the bony lesion was performed. For additional hemostasis during surgery, cotton
pellets soaked in 0.1% epinephrine was applied topically as required.
7. A 2-3mm root tip with a 0º to 10º bevel angle was sectioned with cylindrical surgical
carbide burs at high speed with sterile water coolant.
8. Root end preparations extending 3mm into the canal space along the long axis of the root
was made by using a piezoelectric ultrasonic system with double angled Retrotips coated
with Diamond abrasives.
9. Isthmuses, fins, and other significant anatomic irregularities were identified in high
magnification and was treated with the ultrasonic instruments. Then the resected root
surfaces was stained with methylene blue and were inspected with micromirrors under high
magnification of 24x to examine the cleanliness of the root end preparation and detect
any other overlooked anatomic details.
10. Root end filling were with mineral trioxide aggregrate (MTA). The adaptation of the
filling material to the canal apical walls was confirmed with the aid of an operating
microscope at high magnification.
11. After MTA retrofilling in the test group Collagen membrane was applied on buccal side
and in the control group nothing was apllied and flap will be closed with 4-0 reverse
cutting black silk suture.
RESORBABLE COLLAGEN MEMBRANE:
Bioabsorbable membranes are composed of a wide variety of materials including collagen,
polylactic acid, polyurethane, polyglactin 910, acellular dermal matrix, dura mater,
chitosan, periosteum, and calcium sulfate. The most common material is collagen, which can be
modified through various collagen cross-linking processing techniques to vary the resorption
rate.
Numerous studies have shown bioabsorbable membranes to be effective at promoting regeneration
in both endodontic and periodontal defects. Because alveolar bone and the periodontal
ligament contain collagen, using a collagen membrane might impart some additional advantages
for GTR purposes by augmenting its native properties.
Collagen facilitates hemostasis and therefore wound stability by promoting platelet
aggregation in addition to promoting fibroblast migration, which could accelerate wound
closure. After inspecting the root end filled teeth with microscope and radiographically the
defect will be covered with resorbable collage membrane.
Postoperative instructions:
Care must be taken not to over compress the area. patient should rinse with an appropriate
antimicrobial agent of the clinician's choice (chlorhexidine glucoanate) twice daily for two
weeks. patient should avoid brushing the area for 2 weeks from the surgery date, avoid
flossing for 4 weeks from surgery date. following the first 2 weeks from surgery for the next
3 weeks it is recommended to brush the area only with soft brush.
Post - Operative Follow-Up:
Clinical and radiographic examinations were performed every 3, 6 and 12 months by assessing
the same parameters as baseline except that PD, CAL, and GMP were not measured until 12
months. Routine examination procedure was used to evaluate any evidence of signs and/or
symptoms.
Radiographic evaluations:
Jig radiographs will be taken at 3, 6 and 12th month of follow up. Radiographic healing will
be assessed by the criteria as below.
1. Complete healing, defined by re-establishment of the lamina dura
2. Incomplete healing (scar tissue)
3. Uncertain healing
4. Unsatisfactory healing (failure)
Processing Of Data:
Inter and intra observation of data will be analyzed by distribution of data. Categorical
data will be analyzed by chi square test. Regression analysis will be done to observe any
association between independent and dependent variables. Interobserver/intraobserver
reliability with cohen kappa analysis.
