Periapical DiseasesNCT06643663
Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
A study testing Endodontic Micro-Surgery in people with Periapical Diseases and Endodontic Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases, Endodontic Disease
- What is being tested?
- Endodontic Micro-Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 23 May 2024to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of age 16yrs and above.
- Patients with apico-marginal defects and deep pocket upto apex of tooth.
- Failed primary root canal treatment.
- Presence of interproximal bone loss.
- Negative response to vitality test.
- ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)
Who cannot join
- Presence of vertical root fracture
- Presence of root perforations
- ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists)
- Presence of root resorption
- Combined endodontic-periodontic lesions.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Pgids Rohtak
Haryāna
PARICHAY SINGHAL, PG STUDENT, 9717710642, parichaysinghal11@gmail.com
SHWETA MITTAL, MDS, 9255596960
About this study
Official title: "Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"
The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. More recently, autologous platelet concentrate plug \& placental membrane have emerged as a treatment option for addressing such lesions. Nevertheless, there has been no study using PRF-Medium with ACM membrane on the healing of aforesaid lesion \& quality of life assessment.
Read the detailed description
RESEARCH QUESTION (PICO) Does the combined application of PRF-Medium plug and ACM membrane lead to superior healing outcomes compared to conventional technique in treating apico-marginal defects with interproximal involvement? AIM \&OBJECTIVES: - AIM To assess whether the combined application of PRF-Medium and ACM membrane leads to improved healing outcomes and enhanced quality of life compared to conventional techniques in patients of apico-marinal defects with interproximal involvement. PRIMARY OBJECTIVE
- To evaluate the impact of combined application of PRF-Medium and ACM membrane on healing outcomes in cases of apico-marginal defects with interproximal involvement with 2D periapical radiographs \& 3D CBCT imaging. SECONDARY OBJECTIVE
- To evaluate and compare differences in quality of life of patients after periapical surgery with use of PRF-Medium and ACM membrane in cases of apico-marginal defects with interproximal involvement. PICO P(Population)- Patients with non-vital teeth and persistant chronic suppurative apical periodontitis with apico-marginal defects and interproximal involvement. I(Intervention)-Endodontic surgery followed by placement of PRF-Medium plug and ACM membrane. C(Comparison)-Endodontic surgery without using any plug and membrane. O(Outcome)- Periapical healing after surgery in both groups.
- Conditions
- Periapical Diseases, Endodontic Disease
- Being tested
- Endodontic Micro-Surgery
- Keywords
- Guided tissue regeneration, healing, endo-perio lesions, endodontic surgery
- Medical subject headings
- Periapical Diseases, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic Micro-SurgeryProcedure or surgery
Surgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group.
| Study group | Role | What they receive |
|---|---|---|
| Pt with apicomarginal defects & interproximal bone loss receiving GTR | Experimental | Surgery performed using ACM membrane and PRF plug. Receives: Procedure: Endodontic Micro-Surgery |
| Pt with apicomarginal defects & interproximal bone loss without GTR | Active comparator | Surgery performed without ACM membrane and PRF plug. Receives: Procedure: Endodontic Micro-Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical healing assessment
Periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D Criteria. Healing will be categorised into complete, incomplete, uncertain, unsaisfactory.
Measured: Base line to 12 months
Secondary outcomes (1)
Quality of life assessment
to assess pain, swelling, mouth opening and effect on daily activities of patient among test and control group using OHIP-14 questionnaire. Pain Assesment with Value 0 indicate no pain \& 100 indicate maximum pain.
Measured: Base line to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start23 May 2024
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr, Sanjay Tewari, MDS, Study director, PGIDS, Rohtak, Haryana, 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643663
- Sponsor's protocol ID
- Parichay Singhal
- Status last verified
- Jan 2025
- First submitted
- 22 May 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06643663
- Acronym / sponsor ID
- Parichay Singhal
- Conditions
- Periapical Diseases, Endodontic Disease
- Keywords
- Guided tissue regeneration, healing, endo-perio lesions, endodontic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. More recently, autologous platelet concentrate plug \& placental membrane have emerged as a treatment option for addressing such lesions. Nevertheless, there has been no study using PRF-Medium with ACM membrane on the healing of aforesaid lesion \& quality of life assessment.
Detailed description
RESEARCH QUESTION (PICO) Does the combined application of PRF-Medium plug and ACM membrane lead to superior healing outcomes compared to conventional technique in treating apico-marginal defects with interproximal involvement? AIM \&OBJECTIVES: - AIM To assess whether the combined application of PRF-Medium and ACM membrane leads to improved healing outcomes and enhanced quality of life compared to conventional techniques in patients of apico-marinal defects with interproximal involvement. PRIMARY OBJECTIVE
- To evaluate the impact of combined application of PRF-Medium and ACM membrane on healing outcomes in cases of apico-marginal defects with interproximal involvement with 2D periapical radiographs \& 3D CBCT imaging. SECONDARY OBJECTIVE
- To evaluate and compare differences in quality of life of patients after periapical surgery with use of PRF-Medium and ACM membrane in cases of apico-marginal defects with interproximal involvement. PICO P(Population)- Patients with non-vital teeth and persistant chronic suppurative apical periodontitis with apico-marginal defects and interproximal involvement. I(Intervention)-Endodontic surgery followed by placement of PRF-Medium plug and ACM membrane. C(Comparison)-Endodontic surgery without using any plug and membrane. O(Outcome)- Periapical healing after surgery in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pt with apicomarginal defects & interproximal bone loss receiving GTR | Experimental | Procedure: Endodontic Micro-SurgerySurgery performed using ACM membrane and PRF plug. |
| Pt with apicomarginal defects & interproximal bone loss without GTR | Active comparator | Procedure: Endodontic Micro-SurgerySurgery performed without ACM membrane and PRF plug. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of age 16yrs and above.
- Patients with apico-marginal defects and deep pocket upto apex of tooth.
- Failed primary root canal treatment.
- Presence of interproximal bone loss.
- Negative response to vitality test.
Key exclusion criteria (6 listed)
- Presence of vertical root fracture
- Presence of root perforations
- ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists)
- Presence of root resorption
- Combined endodontic-periodontic lesions.
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 |
|---|---|---|
| Endodontic Micro-SurgerySurgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group. | Procedure or surgery | Pt with apicomarginal defects & interproximal bone loss receiving GTR, Pt with apicomarginal defects & interproximal bone loss without GTR |
Primary outcome
Periapical healing assessment
Time frame: Base line to 12 months
Periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D Criteria. Healing will be categorised into complete, incomplete, uncertain, unsaisfactory.
1 secondary outcome
Quality of life assessment
Time frame: Base line to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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.
Dr, Sanjay Tewari, MDS study director
PGIDS, Rohtak, Haryana, 124001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Micro-Surgery in people with Periapical Diseases and Endodontic Disease, 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shweta Mittal, MDS (9255596960, shwetagoelendo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical healing assessment (time frame: Base line to 12 months). 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 8 Jan 2025.