Trial Title:
Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars
NCT ID:
NCT06643676
Condition:
Periapical Diseases
Periapical Periodontitis
Periapical Cyst
Periapical Granuloma
Periapical Pathology
Endodontic Microsurgery
Targeted Endodontic Microsurgery
Conditions: Official terms:
Radicular Cyst
Periodontitis
Periapical Periodontitis
Periapical Diseases
Periapical Granuloma
Granuloma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
participant will be masked by using the autoclaved guides of other patients with the
guide tubes cut down and conventional surgery done in control group through the guide.
Intervention:
Intervention type:
Procedure
Intervention name:
Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data
Description:
Patients with apical periodontitis with intact cortex in madibular molars receiving
Targeted Endodontic surgery or Guided Endodontic Microsurgery with surgical guide
fabricated using the cbct data following failure of non surgical root canal treatment
Arm group label:
Targeted Endodontic Microsurgery using trephine drill and 3d printed surgical guide
Other name:
periapical surgery, Targeted Endodontic Microsurgery, Guided Endodontic Microsurgery
Other name:
apicoectomy
Intervention type:
Procedure
Intervention name:
Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis
Description:
A conventional endodontic microsurgery using arbitrary localisation technique using the
cbct data and performing the surgery with a carbide bur.
Arm group label:
Conventional Endodontic microsurgery using burs
Summary:
Targeted endodontic microsurgery represents precise and advanced approach to resolving
persisting chronic periapical periodontitis after non- surgical root canal treatment.
This specialised procedure involves accessing the root tip of the tooth under high
magnification using dental operating microscopes and employing microsurgical instruments
to remove infected or inflamed tissue, as well as any pathological lesions present in the
periapical region. Targeted Endodontic Microsurgery is useful for osteotomy and root- end
resection when exacting control of depth, diameter, and angulation of osteotomy and root
end resection is necessary. Using a CBCT(cone beam computed tomography) designed 3D -
printed surgical guideis a more accurate method for access to the apical portion of the
root during surgical endodontics compared with a "freehand" CBCT - approximated
conventional method. These guided have the potential to increase accuracy and precision
and to reduce intraoperative time as well as postoperative complications. Additionally,
it provides a viable treatment option for patients who may not be candidates for
traditional root canal therapy or retreatment due to anatomical complexities or previous
treatment failures.
Detailed description:
Conventional Endodontic microsurgery takes use of a preoperative scan and manual drilling
of the osteotomy site with arbitrary measurements followed by retropreparation and
forming the apical seal. One of the most critical disadvantages of conventional root-end
resection include the damage to anatomically vital structures such as inferior dental
nerve, mental nerve, adjacent root and maxillary sinus. In contrast, endodontic
microsurgery using the guide template significantly reduces these damages. Pinsky et al
confirmed in their in vitro study that the greater accuracyand consistency was achieved
during endodontic surgery with surgical guidance without damaging vital structures. An
error greater than 3 mm occurred over 22% of the time with freehand whereas none of
errors occurred with surgical guidance.
Consequently, targeted endodontic microsurgery has garnered increasing attention as a
viable alternative, offering a refined and precise approach to address such challenges.
Even the most skilled surgeons may find endodontic microsurgery difficult. Some medical
professionals steer clear using freehand (FH) Endodontic microsurgery in regions where
there is a chance of harming important anatomical features including the maxillary sinus,
the mental foramen, and arteries. It is Perceived as complex sites include those with
limited access, no direct sight, and areas where the apex is placed distant from the
buccal cortical bone without any cortical plate fenestratio. Surgeons may be able to
perform precise procedures in difficult-to-reach regions with guided Endodontic
Microsurgery
Guided Endodontic Microsurgery is virtually planned on 3D software on the preoperative
CBCT scan, and the surgeon executes the osteotomy and root-end resection (RER) under
static or dynamic navigation.
Static navigation requires a customized 3D-printed surgical guide (3D-SG) to guide the
drilling duringosteotomy and RER. Surgical guides contain a guide template that refers to
the 3D location of the virtual Endodontic Microsurgery planned in the CBCT to drill
accurately Prior research has demonstrated that 3D-SG can reduce the risk of
intra-operative complications whileincreasing the precision and effectiveness of EMS. In
comparison to free hand Endodontic Microsurgery, guided Endodontic Microsurgery with
3D-Surgical Guide shortens the surgical time, provides superior control over the
resection level and bevel off the root, and enables a tailored osteotomy size.
Trephine burs have been used for the removal of failed implants and autogenous bone graft
harvesting but have not previously been described in Endodontic Microsurgery .
Targeted Endodontic Microsurgery produces a single-step osteotomy; root-end resection;
and biopsy with a defined perforation site, angulation, depth, and diameter. Previous
reports have used 3D Surgical Guides to locate an ideal bone perforation site, but none
have used trephine burs within a stent to define all parameters of osteotomy and root-end
resection.
Also, no clinical study assessing the targeted approach of endodontic microsurgery with
Oral health related quality of life has been done. Some of the RCT's are conducted
assessing quality of life in patients after conventional periapical surgery, only two
retrospective studies considering .Targeted Endodontic Microsurgery have been done and a
lack of RCTs comparing targeted Endodontic Microsurgery with conventionalEMS warrants
further research.
The aim of this study is to compare the effect of a static computer-aided surgical
technique using a 3D- printed guide with a fully guided drill protocol on Oral Health
Related Quality of Life against the conventional endodontic microsurgery in mandibular
molars.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients between 18-55 years of age
- No general medical contraindications for oral surgical procedures (ASA-1 according
to the classification of the American Society of Anesthesiologists)
- ASA 1- A normal healthy patient. Example: Fit, non-obese (BMI under 30), a
nonsmoking patient with good exercise tolerance.
- Tooth with a peri-radicular lesion of strictly endodontic origin (Symptomatic and
Asymptomatic apical periodontitis) with the size of lesion 5mm≤10mm and intact
cortical bony plate in CBCT
- Tooth with non-surgical retreatment unfeasible or previously failed (post, anatomy,
or iatrogenic complications like irrepairable ledges, separated instruments and
apical transportation) Tooth with adequate final restoration without clinical
evidence of coronal leakage but with persisting periodontal lesion.
- No spontaneous pain or swelling
- Periodontically healthy teeth at tooth level.
Exclusion Criteria:
- Presence of vertical root fracture
- Presence of root perforations
- Miller class III/IV mobility
- Presence of root resorption
- Combined Endodontic-Periodontic lesions
- Pregnancy
- Patients with neuropsychiatric disorders and other systemic conditions
- Smokers.
Gender:
All
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Post Graduate Institute of Dental Sciences , Rohtak
Address:
City:
Rohtak
Zip:
124001
Country:
India
Status:
Recruiting
Contact:
Last name:
MOHAMMED MUZAFFAR KHAN, BDS
Phone:
9500728585
Email:
mohmuzaffar.khann@gmail.com
Contact backup:
Last name:
Jigyasa grover, MDS
Phone:
919896270449
Email:
jigyasaduhan1976@gmail.com
Investigator:
Last name:
Mohammed muzaffar Khan, BDS
Email:
Principal Investigator
Investigator:
Last name:
Jigyasa Grover, MDS
Email:
Sub-Investigator
Investigator:
Last name:
Sanjay Tewari, MDS
Email:
Sub-Investigator
Investigator:
Last name:
Mayank Arora, MDS
Email:
Sub-Investigator
Investigator:
Last name:
Harneet Singh, MDS
Email:
Sub-Investigator
Investigator:
Last name:
Deepak Chhabra, PHD
Email:
Sub-Investigator
Start date:
July 1, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Postgraduate Institute of Dental Sciences Rohtak
Agency class:
Other
Source:
Postgraduate Institute of Dental Sciences Rohtak
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06643676
