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A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates

A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04389346
Enrollment
32
Registered
2020-05-15
Start date
2019-07-01
Completion date
2021-03-31
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Apical Periodontitis

Keywords

Apicomarginal defects, Cone Beam Computed Tomography, Autologous platelet aggregate

Brief summary

This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.

Detailed description

Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.

Interventions

PROCEDUREPeriapical surgery using autologous platelet aggregate

PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning

PROCEDUREPeriapical surgery without autologous platelet aggregate

Flap will be repositioned following apicoectomy directly without placing any platelet aggregate

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures. * Apicomarginal communication having probing depth \> 6mm. * Patients with no general medical contraindications for oral surgical procedures. * Recurrent episodes of purulent discharge. * Failed previous root canal treatment. * Failed previous surgery with persistent bony lesion. * Adequate final restoration with no clinical evidence of coronal leakage.

Exclusion criteria

* Clinical or radiographic evidence of root fracture. * Resorptive processes involving more than apical third of the root. * Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy. * Any condition effecting rate of healing like smoking.

Design outcomes

Primary

MeasureTime frameDescription
Change in periapical radiolucencyBaseline to 12 Months2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 months by following scoring scores for 2D healing Score1-Complete healing defined by re-establishment of the lamina dura Score 2- Incomplete healing (scar tissue) Score 3- Uncertain healing Score 4- Unsatisfactory healing scores for 3D healing Score1- Complete healing Score 2- Limited healing Score 3- Uncertain healing Score 4- Unsatisfactory healing

Secondary

MeasureTime frameDescription
Clinical successBaseline to 12 MonthsClinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion

Countries

India

Contacts

Primary ContactDR PANKAJ SANGWAN
drps_1@yahoo.com9996112202
Backup ContactANKITA RAMANI
ramaniankita95@gmail.com9582841539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026