Intrabony Periodontal DefectNCT04100798
Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
A study testing Entire Papilla Preservation technique and Modified Minimally invasive Surgical Technique in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
Trial summary
Periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. This would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (Tonetti… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Entire Papilla Preservation technique and Modified Minimally invasive Surgical Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2020to 15 Nov 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients age between 20 and 60 years old.
- Stage III periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- Defect not extending to a root furcation area.
- Vital teeth
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- Patients who are cooperative, motivated, and hygiene conscious.
Who cannot join
- Any systemic disease that contra-indicates periodontal surgery or may affect healing.
- Smokers
- Pregnant females
- Drug abusers
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. This would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (Tonetti, Greenwell, \& Kornman, 2018).
The main objective of periodontal surgeries is directed at complete preservation of the interdental soft tissues to achieve primary closure over the intraosseous defected sites during the early phases of wound healing. Evidence shows that surgical techniques are highly predictable in the treatment of pockets associated with deep and shallow intrabony defects affected majorly by the selected flap design. The purpose of the flap design of minimally invasive periodontal surgery is to overcome the drawbacks of conventional periodontal surgeries decreasing the surgical trauma, improving the clot stability, reducing patient discomfort post operatively and minimizing the surgical chair time (Aslan, Buduneli, \& Cortellini, 2017b) Modified Minimally Invasive Surgical Technique (M-MIST) is considered one of the latest minimally invasive techniques that have been used in the treatment of intraosseous defects, this technique however entails an incision over the defect-associated interdental papilla that may jeopardize the volume and complex vascular integrity of the interdental tissues, lacking the special flap design that would emphasis clot stability for better wound healing. Where a new surgical technique turned entire papilla preservation has been developed for protection of the wound without affecting the vascularity of the area. (Pierpaolo Cortellini \& Tonetti, 2015) This randomized clinical trial compared the clinical and radiographic efficacy of entire papilla preservation surgical technique (EPP) to Modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intraosseous defects in stage III periodontitis patients.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Entire Papilla Preservation technique, Modified Minimally invasive Surgical Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entire Papilla Preservation techniqueProcedure or surgery
Also called EPP
A minimally invasive technique that allow access to the intrabony defect without affecting the interdental papilla related to it
Modified Minimally invasive Surgical TechniqueProcedure or surgery
Also called M-MIST
a minimally invasive technique that allow access to the intrabony defect area from the buccal aspect through a horizontal incision below the papilla without elevating it.
| Study group | Role | What they receive |
|---|---|---|
| Entire Papilla Preservation (EPP) technique | Experimental | A minimally invasive surgical technique that involves using a vertical incision away from the defect area in order to preserve the integrity of the related interdental papilla and elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap Receives: Procedure: Entire Papilla Preservation technique |
| Modified Minimally invasive Surgical Technique (M-MIST) | Active comparator | A minimally invasive surgical technique that involves using a horizontal interdental incision that extends to the buccal aspect of the two teeth adjacent to the intraosseous defect then elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap Receives: Procedure: Modified Minimally invasive Surgical Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment Level gain (CAL gain)
CAL gain will be determined by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC 15 periodontal probe.
Measured: 12 months
Secondary outcomes (5)
Pocket depth (PD)
Probing depth will be measured from the gingival margin to the base of the periodontal pocket using a UNC 15 periodontal probe.
Measured: 12 months
Gingival recession (GR)
Gingival recession will be measured using UNC periodontal probe from the cemento-enamel junction till the gingival margin (Ainamo \& Bay, 1975).
Measured: 12 months
Radiographic defect fil
The depth of intra-bony defect (IBD) will be measured from the alveolar bone crest to the base of the defect to detect the amount of bone fill Radiographs will be scanned and the radiographic IBD depth will be measured by a computer-aided software program
Measured: 12 months
Gingival bleeding score
- Gingival bleeding score will be performed through gentle probing of the orifice of the gingival crevice from all four surfaces of all teeth using UNC Periodontal probe.
- Recorded as (+) if bleeding is present or (-) if bleeding is absent.
- If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined
Measured: 12 months
Post-surgical patient satisfaction
- Three questionnaires will be asked to determine patients' satisfaction with the outcome of surgery
- Considering this was an elective operation, how likely would you be to recommend it to others?
- If you had to make the decision again, how likely would you be to undergo this surgery'?
- Considering everything, how satisfied are you with the outcome of your surgery
- These questions could all be answered by the patient using a 7-point response scale where: Very Satisfied = 7; Not At All Satisfied = 1. (H. A. Kiyak et al., 1984)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start8 Feb 2020
- Primary completion2 Sep 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ebrahim Mohamed Mokhtar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100798
- Sponsor's protocol ID
- PER 3-3-2
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04100798
- Acronym / sponsor ID
- PER 3-3-2
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 24 Sep 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.
Periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. This would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (Tonetti, Greenwell, \& Kornman, 2018).
The main objective of periodontal surgeries is directed at complete preservation of the interdental soft tissues to achieve primary closure over the intraosseous defected sites during the early phases of wound healing. Evidence shows that surgical techniques are highly predictable in the treatment of pockets associated with deep and shallow intrabony defects affected majorly by the selected flap design. The purpose of the flap design of minimally invasive periodontal surgery is to overcome the drawbacks of conventional periodontal surgeries decreasing the surgical trauma, improving the clot stability, reducing patient discomfort post operatively and minimizing the surgical chair time (Aslan, Buduneli, \& Cortellini, 2017b) Modified Minimally Invasive Surgical Technique (M-MIST) is considered one of the latest minimally invasive techniques that have been used in the treatment of intraosseous defects, this technique however entails an incision over the defect-associated interdental papilla that may jeopardize the volume and complex vascular integrity of the interdental tissues, lacking the special flap design that would emphasis clot stability for better wound healing. Where a new surgical technique turned entire papilla preservation has been developed for protection of the wound without affecting the vascularity of the area. (Pierpaolo Cortellini \& Tonetti, 2015) This randomized clinical trial compared the clinical and radiographic efficacy of entire papilla preservation surgical technique (EPP) to Modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intraosseous defects in stage III periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entire Papilla Preservation (EPP) technique | Experimental | Procedure: Entire Papilla Preservation techniqueA minimally invasive surgical technique that involves using a vertical incision away from the defect area in order to preserve the integrity of the related interdental papilla and elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap |
| Modified Minimally invasive Surgical Technique (M-MIST) | Active comparator | Procedure: Modified Minimally invasive Surgical TechniqueA minimally invasive surgical technique that involves using a horizontal interdental incision that extends to the buccal aspect of the two teeth adjacent to the intraosseous defect then elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients age between 20 and 60 years old.
- Stage III periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- Defect not extending to a root furcation area.
- Vital teeth
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
Key exclusion criteria (4 listed)
- Any systemic disease that contra-indicates periodontal surgery or may affect healing.
- Smokers
- Pregnant females
- Drug abusers
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 |
|---|---|---|
| Entire Papilla Preservation techniqueAlso: EPPA minimally invasive technique that allow access to the intrabony defect without affecting the interdental papilla related to it | Procedure or surgery | Entire Papilla Preservation (EPP) technique |
| Modified Minimally invasive Surgical TechniqueAlso: M-MISTa minimally invasive technique that allow access to the intrabony defect area from the buccal aspect through a horizontal incision below the papilla without elevating it. | Procedure or surgery | Modified Minimally invasive Surgical Technique (M-MIST) |
Primary outcome
Clinical attachment Level gain (CAL gain)
Time frame: 12 months
CAL gain will be determined by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC 15 periodontal probe.
5 secondary outcomes
Pocket depth (PD)
Time frame: 12 months
Gingival recession (GR)
Time frame: 12 months
Radiographic defect fil
Time frame: 12 months
Gingival bleeding score
Time frame: 12 months
Post-surgical patient satisfaction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Intrabony Periodontal Defect
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use
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 Entire Papilla Preservation technique and Modified Minimally invasive Surgical Technique in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 22 Feb 2022. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical attachment Level gain (CAL gain) (time frame: 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 22 Feb 2022.