Periapical LesionNCT04391725
Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion
A study testing Periapical surgery with guided tissue regeneration and Periapical surgery without anyguided tissue regeneration in people with Periapical Lesion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Periapical Lesion
- What is being tested?
- Periapical surgery with guided tissue regeneration and Periapical surgery without anyguided tissue regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 11 Dec 2019to 11 Apr 2021
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of age 16-55 years with a clinical \& radiographic diagnosis of through and through periradicular lesion using CBCT
- Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
- Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
- The teeth must have adequate final restoration with no clinical evidence of coronal leakage.
Who cannot join
- Unrestorable tooth.
- Fractured / perforated tooth.
- Systemic diseases contraindicating surgical procedures or with potential to affect healing.
- Teeth with deep pockets.
- Patient requiring antibiotic premedication.
- Patients with history of antibiotic use in last 3 months.
- Smokers
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Sanjay Tewari
Rohtak, Haryana, 124001
Sanjay Tewari, MDS, 9416259534, principalpgids@yahoo.in
About this study
Official title: Healing Following Use Of Injectable Platelet Rich Fibrin With Collagen During Surgery In Through And Through Periapical Lesions
Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery
Read the detailed description
Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.
- Conditions
- Periapical Lesion
- Being tested
- Periapical surgery with guided tissue regeneration, Periapical surgery without anyguided tissue regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical surgery with guided tissue regenerationProcedure or surgery
periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules
Periapical surgery without anyguided tissue regenerationProcedure or surgery
periapical surgery will be done followed by flap closure
| Study group | Role | What they receive |
|---|---|---|
| Periapical surgery with guided tissue regeneration | Experimental | Patients with through and through periapical lesion will undergo periapical surgery and the defect is filled with mixture of iPRF and type 1 collagen granules before flap closure. Receives: Procedure: Periapical surgery with guided tissue regeneration |
| Periapical surgery without any guided tissue regeneration | Active comparator | Patients with through and through periapical lesion will undergo periapical surgery and flap closure done. Receives: Procedure: Periapical surgery without anyguided tissue regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in periapical radiolucency at 12 months
2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 month with following scoring scores for 2D healing Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure)
scores for 3D healing Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing
Measured: baseline to 12 months
Secondary outcomes (1)
change in Quality of life from baseline to 7 days
caliberated operator will score the quality of life questionnaire in patients following surgical endodontic treatment
Measured: postoperative Day 1 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start11 Dec 2019
- Primary completion11 Dec 2020 (estimated)
- Study completion11 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical LesionStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391725
- Sponsor's protocol ID
- Arpitha CM
- Status last verified
- Dec 2019
- First submitted
- 13 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
M A, S T, P S, A G. Efficacy of mixture of injectable-platelet-rich fibrin and type-1 collagen particles on the closure of through-and-through periapical bone defects: A randomized controlled trial. Int Endod J. 2023 Oct;56(10):1197-1211. doi: 10.1111/iej.13954. Epub 2023 Jul 17.
PubMed 37418583
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Following Use Of Injectable Platelet Rich Fibrin With Collagen During Surgery In Through And Through Periapical Lesions
- ClinicalTrials.gov ID
- NCT04391725
- Acronym / sponsor ID
- Arpitha CM
- Conditions
- Periapical Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 11 Dec 2020 (estimated)
- Study completion
- 11 Apr 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery
Detailed description
Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periapical surgery with guided tissue regeneration | Experimental | Procedure: Periapical surgery with guided tissue regenerationPatients with through and through periapical lesion will undergo periapical surgery and the defect is filled with mixture of iPRF and type 1 collagen granules before flap closure. |
| Periapical surgery without any guided tissue regeneration | Active comparator | Procedure: Periapical surgery without anyguided tissue regenerationPatients with through and through periapical lesion will undergo periapical surgery and flap closure done. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients of age 16-55 years with a clinical \& radiographic diagnosis of through and through periradicular lesion using CBCT
- Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
- Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
- The teeth must have adequate final restoration with no clinical evidence of coronal leakage.
Key exclusion criteria (7 listed)
- Unrestorable tooth.
- Fractured / perforated tooth.
- Systemic diseases contraindicating surgical procedures or with potential to affect healing.
- Teeth with deep pockets.
- Patient requiring antibiotic premedication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periapical surgery with guided tissue regenerationperiapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules | Procedure or surgery | Periapical surgery with guided tissue regeneration |
| Periapical surgery without anyguided tissue regenerationperiapical surgery will be done followed by flap closure | Procedure or surgery | Periapical surgery without any guided tissue regeneration |
Primary outcome
change from baseline in periapical radiolucency at 12 months
Time frame: baseline to 12 months
2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 month with following scoring scores for 2D healing Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure) scores for 3D healing Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing
1 secondary outcome
change in Quality of life from baseline to 7 days
Time frame: postoperative Day 1 to day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Derived from this study: PubMed 37418583M A, S T, P S, A G. Efficacy of mixture of injectable-platelet-rich fibrin and type-1 collagen particles on the closure of through-and-through periapical bone defects: A randomized controlled trial. Int Endod J. 2023 Oct;56(10):1197-1211. doi: 10.1111/iej.13954. Epub 2023 Jul 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periapical surgery with guided tissue regeneration and Periapical surgery without anyguided tissue regeneration in people with Periapical Lesion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in periapical radiolucency at 12 months (time frame: baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391725, which also lists 1 linked publication.
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 18 May 2020.