Apico Marginal DefectsNCT03905590
Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication Using CBCT
A study testing Periapical surgery with amniotic membrane and periapical surgery without amniotic membrane in people with Apico Marginal Defects, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Healing of the Apicomarginal defects will be checked by comparing 2 groups . In first group amniotic membrane will be applied over the defect before flap closure during surgery and in second group no GTR material will be applied. Healing of the lesions will also be compared 2 dimensionaly and 3 dimensionaly using CBCT Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apico Marginal Defects
- What is being tested?
- Periapical surgery with amniotic membrane and periapical surgery without amniotic membrane
- 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
- 1 Jan 2018to May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of age 16 years and above.
- Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's.
- periapical defect with periodontal communication.
- Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
- Negative response to vitality test.
- failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
Who cannot join
- Presence of buccal bone on flap elevation.
- Unrestorable tooth.
- fractured /perforated roots.
- smokers.
- pregnant females and lactating mothers
- .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication :A Randomized Controlled Trial With 3D Analysis Using CBCT."
Healing of the Apicomarginal defects will be checked by comparing 2 groups . In first group amniotic membrane will be applied over the defect before flap closure during surgery and in second group no GTR material will be applied. Healing of the lesions will also be compared 2 dimensionaly and 3 dimensionaly using CBCT
Read the detailed description
Study Title: - To evaluate the efficacy of guided tissue regeneration in the healing of periapical defects with periodontal communication: A randomized controlled trial with 3D analysis using CBCT.
Rationale: - Healing of lesions with apicomarginal defects is often less satisfactory. Various studies and case reports have reported high success rate with the use of guided tissue regeneration technique. Only few clinical trials have evaluated the effect of guided tissue regeneration on the healing of apicomarginal defects. To best of our knowledge only two studies have conducted randomized controlled trial. However, no study has used CBCT for the assessment of healing in such type of lesions. So, this is the first randomized controlled trial studying the effect of guided tissue regeneration in the healing of periapical defects with periodontal communication using 3D radiological evaluation using CBCT.
Aim \& Objectives: - 1. To evaluate the difference in the healing outcome of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique 2. To evaluate the difference in the healing outcome derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.
Study Design: - A randomized controlled trial Time Frame: - 12 to 18 months Population / Participants: - Patients of age 16 years (male/female) and above will be enrolled in the study.
Inclusion criteria: - Patients of age 16 years and above, Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's, periapical defect with periodontal communication, periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root ., -ve response to vitality test, failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
Exclusion criteria: -Presence of buccal bone on flap elevation, Unrestorable tooth, fractured /perforated roots, smokers, pregnant females and lactating mothers.
Sample size: - 30 patients (15 patients in each group) Methods: - Diagnosis of the lesion will be made clinically and radiographically, vitality will be checked by EPT, preoperative clinical evaluation will include, clinical attachment level, gingival marginal position and pocket depth. Marginal bone loss, width of bony crypt, height of the bony crypt, depth of the crypt and height of the buccal bone plate (if present) will be measured radiographically and at the time of surgery. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by the standardized treatment methods.
Outcome measures: - Follow up of patients will be carried out at 3, 6, 9 \& 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
Statistical method: - The data will be entered into Microsoft Excel and analysed using SPSS (Statistical Package for Social Science) package for relevant statistical comparison. Distribution of data into normal and non-normal will be done by Kolmogorov-Smir-Nov test. If the data will be normal then student T test and paired T test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.
If the data will be non-normal then Mann - Whitney and Wilcoxon rank sum test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.
- Conditions
- Apico Marginal Defects
- Being tested
- Periapical surgery with amniotic membrane, periapical surgery without amniotic membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical surgery with amniotic membraneProcedure or surgery
periapical surgery will be done followed by amniotic membrane placement over the defect
periapical surgery without amniotic membraneProcedure or surgery
periapical surgery will be done without placement of membrane over the defect.
| Study group | Role | What they receive |
|---|---|---|
| periapical surgery with amniotic membrane | Experimental | periapical surgery will be done and amniotic membrane will be placed over the defect before closure of flap Receives: Procedure: Periapical surgery with amniotic membrane |
| periapical surgery without amniotic membrane | Active comparator | periapical surgery will be done without the placement of amniotic membrane over the defect before closure of flap Receives: Procedure: periapical surgery without amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique
Follow up of patients will be carried out at 3, 6, 9 \& 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
Measured: BASE LINE TO 1YEAR
Secondary outcomes (1)
the difference in the healing outcome as observed derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
The comparison of healing will be done 2 dimensionaly and 3 dimensionaly
Measured: BASE LINE TO 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Jan 2018
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apico Marginal DefectsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT03905590
- Sponsor's protocol ID
- RITIKA YADAV
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication :A Randomized Controlled Trial With 3D Analysis Using CBCT."
- ClinicalTrials.gov ID
- NCT03905590
- Acronym / sponsor ID
- RITIKA YADAV
- Conditions
- Apico Marginal Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 5 Apr 2019 (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.
Healing of the Apicomarginal defects will be checked by comparing 2 groups . In first group amniotic membrane will be applied over the defect before flap closure during surgery and in second group no GTR material will be applied. Healing of the lesions will also be compared 2 dimensionaly and 3 dimensionaly using CBCT
Detailed description
Study Title: - To evaluate the efficacy of guided tissue regeneration in the healing of periapical defects with periodontal communication: A randomized controlled trial with 3D analysis using CBCT.
Rationale: - Healing of lesions with apicomarginal defects is often less satisfactory. Various studies and case reports have reported high success rate with the use of guided tissue regeneration technique. Only few clinical trials have evaluated the effect of guided tissue regeneration on the healing of apicomarginal defects. To best of our knowledge only two studies have conducted randomized controlled trial. However, no study has used CBCT for the assessment of healing in such type of lesions. So, this is the first randomized controlled trial studying the effect of guided tissue regeneration in the healing of periapical defects with periodontal communication using 3D radiological evaluation using CBCT.
Aim \& Objectives: - 1. To evaluate the difference in the healing outcome of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique 2. To evaluate the difference in the healing outcome derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.
Study Design: - A randomized controlled trial Time Frame: - 12 to 18 months Population / Participants: - Patients of age 16 years (male/female) and above will be enrolled in the study.
Inclusion criteria: - Patients of age 16 years and above, Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's, periapical defect with periodontal communication, periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root ., -ve response to vitality test, failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
Exclusion criteria: -Presence of buccal bone on flap elevation, Unrestorable tooth, fractured /perforated roots, smokers, pregnant females and lactating mothers.
Sample size: - 30 patients (15 patients in each group) Methods: - Diagnosis of the lesion will be made clinically and radiographically, vitality will be checked by EPT, preoperative clinical evaluation will include, clinical attachment level, gingival marginal position and pocket depth. Marginal bone loss, width of bony crypt, height of the bony crypt, depth of the crypt and height of the buccal bone plate (if present) will be measured radiographically and at the time of surgery. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by the standardized treatment methods.
Outcome measures: - Follow up of patients will be carried out at 3, 6, 9 \& 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
Statistical method: - The data will be entered into Microsoft Excel and analysed using SPSS (Statistical Package for Social Science) package for relevant statistical comparison. Distribution of data into normal and non-normal will be done by Kolmogorov-Smir-Nov test. If the data will be normal then student T test and paired T test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.
If the data will be non-normal then Mann - Whitney and Wilcoxon rank sum test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periapical surgery with amniotic membrane | Experimental | Procedure: Periapical surgery with amniotic membraneperiapical surgery will be done and amniotic membrane will be placed over the defect before closure of flap |
| periapical surgery without amniotic membrane | Active comparator | Procedure: periapical surgery without amniotic membraneperiapical surgery will be done without the placement of amniotic membrane over the defect before closure of flap |
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 16 years and above.
- Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's.
- periapical defect with periodontal communication.
- Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
- Negative response to vitality test.
Key exclusion criteria (6 listed)
- Presence of buccal bone on flap elevation.
- Unrestorable tooth.
- fractured /perforated roots.
- smokers.
- pregnant females and lactating mothers
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 amniotic membraneperiapical surgery will be done followed by amniotic membrane placement over the defect | Procedure or surgery | periapical surgery with amniotic membrane |
| periapical surgery without amniotic membraneperiapical surgery will be done without placement of membrane over the defect. | Procedure or surgery | periapical surgery without amniotic membrane |
Primary outcome
healing of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique
Time frame: BASE LINE TO 1YEAR
Follow up of patients will be carried out at 3, 6, 9 \& 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
1 secondary outcome
the difference in the healing outcome as observed derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
Time frame: BASE LINE TO 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 amniotic membrane and periapical surgery without amniotic membrane in people with Apico Marginal Defects, 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique (time frame: BASE LINE TO 1YEAR). 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 5 Apr 2019.