Minimally Invasive Surgical TechniqueNCT03570736
Evaluation of Gain In Clinical Attachment And Bone Levels After Treatment of Patients With Intra-bony Defects By Minimally Invasive Surgical Technique Versus Open Flap Debridement.
A study testing Minimal invasive surgical technique and Open Flap Debridement in people with Minimally Invasive Surgical Technique and Open Flap Debridement, run by Cairo University.
Trial summary
Hypothesis:The conventional surgical approach is to raise large flaps to completely and exceedingly expose the area of interest. Since the results were unsatisfactory due to limited regenerated periodontal tissue, an alternative approach to access the intra-bony defects was proposed, this approach is called minimally… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minimally Invasive Surgical Technique, Open Flap Debridement, Microsurgery
- What is being tested?
- Minimal invasive surgical technique and Open Flap Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25 years of age or older.
- At least one periodontal infrabony pocket (detected radiographically) with Probing depth (PD) ≥5 mm,
- Plaque index < 30 %
Who cannot join
- Hopeless tooth.
- Previous periodontal surgery within the last 2 years in area of interest.
- Systemic conditions which are generally considered to be a contraindication to periodontal surgery which included but not limited to: osteoporosis, uncontrolled diabetes.
- Pregnant or lactating females
- Current or former smokers.
- Non compliant patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Gain In Clinical Attachment And Bone Levels After Treatment of Patients With Intra-bony Defects By Minimally Invasive Surgical Technique Versus Open Flap Debridement. A Randomized Controlled Clinical Trial
Hypothesis:The conventional surgical approach is to raise large flaps to completely and exceedingly expose the area of interest. Since the results were unsatisfactory due to limited regenerated periodontal tissue, an alternative approach to access the intra-bony defects was proposed, this approach is called minimally invasive techniques which use incisions just large enough for debridement and generally involves reflecting the papilla only using specialized instruments to access the intra-bony defect and debridement.
Aim of the study:Is to evaluate the gain in clinical attachment level and bone after treatment of the intra-bony defects by Minimally Invasive Surgical Technique when compared to Open Flap Debridement in patients with intra-bony defects.
Read more
Study setting:Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Oral and Dental Medicine - Cairo University, Egypt.Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Prior to the start of the study each patient will receive initial periodontal therapy consisting of proper oral hygiene instructions and full-mouth scaling and root planing. Six weeks after completion of the initial therapy, a re-evaluation will be performed to confirm that the patients meet all the inclusion criteria for the study.
Evaluation of the patient's oral hygiene and a written consent will be obtained from the patients who will participate in the trial. Blinded periodontist will record the clinical measurements prior to surgery using a periodontal probe.
Prior to surgery, a stent will be fabricated for each site using diagnostic casts and acrylic resin. Each stent will rest on the occlusal surfaces of at least 4 teeth and had a vertical notch marking the facial and lingual position of the intra-bony defect. A periapical radiograph using paralleling technique using extension cone paralleling (XCP) film holder will be performed for each patient to evaluate alveolar bone loss using DIGORA system.
Surgical procedure:The patients will be randomly assigned into two groups; Group A (Control): Patients receiving Open Flap Debridement (OFD). Group B (Test): Patients receiving Minimally Invasive Surgical technique (MIST).
The operator will anesthetize the surgical sites for both groups. For the OFD technique, buccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect.
Surgical debridement will be carried out to remove subgingival plaque, calculus and granulation tissue. The surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level with 5-0 vicryl suture utilizing a vertical mattress suturing technique achieving primary closure.
For the Minimally Invasive Surgical technique, it will be carried out with 2.5 X optical magnification dental loupes. After local anaesthesia, an envelope flap without vertical releasing incisions will be performed. The defect-associated interdental papilla will be accessed either with the simplified papilla preservation flap (SPPF) in narrow interdental spaces or the modified papilla preservation technique (MPPT) in large interdental spaces. In the SPPF, a diagonal incision traced as close as possible to the buccal side of the papilla col will be performed, whereas in the MPPT a horizontal incision traced on the buccal side of the papilla will be done. Intrasulcular incisions will be performed from the interdental side to the buccal and lingual sides of the teeth neighboring the defect; tiny buccal and lingual flaps will be elevated to expose the bone crest.
All incisions will be done using microsurgical ophthalmic blades. Buccal and lingual flaps will be elevated using sharp dissection only. Granulation tissue adherent to the inner surface of flaps will be carefully removed with microscissors to provide full access and visibility to root surfaces. Defect debridement and root planing will be performed with a combination of mini-curettes. Then sutures will be placed using 6-0 vicryl suture.
Postoperative medication:Administration of amoxicillin (500 mg tabs) T.I.D for 7 days), Chlorhexidine rinse (B.I.D for 14 days). Ibuprofen 600 mg tabs 1 every 8h in case of unbearable pain.
Patient self-care instructions: Sutures will be removed 2 weeks post-surgically. Patients will be asked to abstain from mechanical oral hygiene procedures in the surgical area for 2 weeks. After this period, patients will be instructed to continue mechanical tooth brushing again of the treated sites using a soft toothbrush.
The outcomes will be measured at 1 week, 3 and 6 months post-operatively.
- Being tested
- Minimal invasive surgical technique, Open Flap Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive surgical techniqueProcedure or surgery
Minimal Invasive Surgical technique using either Modified Papilla Preservation or Simplified Papilla Preservation Technique.
Open Flap DebridementProcedure or surgery
Buccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Surgical Technique | Experimental | Not described Receives: Procedure: Minimal invasive surgical technique |
| Open Flap Debridement | Active comparator | Not described Receives: Procedure: Open Flap Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
It is the distance measured from the cemento-enamel junction (CEJ) to the bottom of the pocket.
Measured: up to 6 months post-operatively
Secondary outcomes (4)
Probing Depth
It is the distance measured from the gingival margin to the bottom of the pocket.
Measured: up to 6 months post-operatively
Gingival Recession
It is the distance measured from the CEJ to the most apical extension of gingival margin.
Measured: up to 6 months post-operatively
Post-Operative Pain
It wil be measured by Visual Analogue Scale (VAS) with numbers from 0 to 10 (0 indicates 'no pain' to 10 which indicates 'worst pain imaginable')
Measured: up to 1 week post-operatively
Bone Fill
It will be measured radio-graphically by DIGORA system
Measured: up to 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgical TechniqueStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal El Din Abd El Salam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570736
- Sponsor's protocol ID
- 12348765
- Status last verified
- Jun 2018
- First submitted
- 14 Jun 2018
- Last updated
- 27 Jun 2018
- 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gain In Clinical Attachment And Bone Levels After Treatment of Patients With Intra-bony Defects By Minimally Invasive Surgical Technique Versus Open Flap Debridement. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03570736
- Acronym / sponsor ID
- 12348765
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 27 Jun 2018 (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.
Hypothesis:The conventional surgical approach is to raise large flaps to completely and exceedingly expose the area of interest. Since the results were unsatisfactory due to limited regenerated periodontal tissue, an alternative approach to access the intra-bony defects was proposed, this approach is called minimally invasive techniques which use incisions just large enough for debridement and generally involves reflecting the papilla only using specialized instruments to access the intra-bony defect and debridement.
Aim of the study:Is to evaluate the gain in clinical attachment level and bone after treatment of the intra-bony defects by Minimally Invasive Surgical Technique when compared to Open Flap Debridement in patients with intra-bony defects.
Study setting:Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Oral and Dental Medicine - Cairo University, Egypt.Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Prior to the start of the study each patient will receive initial periodontal therapy consisting of proper oral hygiene instructions and full-mouth scaling and root planing. Six weeks after completion of the initial therapy, a re-evaluation will be performed to confirm that the patients meet all the inclusion criteria for the study.
Evaluation of the patient's oral hygiene and a written consent will be obtained from the patients who will participate in the trial. Blinded periodontist will record the clinical measurements prior to surgery using a periodontal probe.
Prior to surgery, a stent will be fabricated for each site using diagnostic casts and acrylic resin. Each stent will rest on the occlusal surfaces of at least 4 teeth and had a vertical notch marking the facial and lingual position of the intra-bony defect. A periapical radiograph using paralleling technique using extension cone paralleling (XCP) film holder will be performed for each patient to evaluate alveolar bone loss using DIGORA system.
Surgical procedure:The patients will be randomly assigned into two groups; Group A (Control): Patients receiving Open Flap Debridement (OFD). Group B (Test): Patients receiving Minimally Invasive Surgical technique (MIST).
The operator will anesthetize the surgical sites for both groups. For the OFD technique, buccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect.
Surgical debridement will be carried out to remove subgingival plaque, calculus and granulation tissue. The surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level with 5-0 vicryl suture utilizing a vertical mattress suturing technique achieving primary closure.
For the Minimally Invasive Surgical technique, it will be carried out with 2.5 X optical magnification dental loupes. After local anaesthesia, an envelope flap without vertical releasing incisions will be performed. The defect-associated interdental papilla will be accessed either with the simplified papilla preservation flap (SPPF) in narrow interdental spaces or the modified papilla preservation technique (MPPT) in large interdental spaces. In the SPPF, a diagonal incision traced as close as possible to the buccal side of the papilla col will be performed, whereas in the MPPT a horizontal incision traced on the buccal side of the papilla will be done. Intrasulcular incisions will be performed from the interdental side to the buccal and lingual sides of the teeth neighboring the defect; tiny buccal and lingual flaps will be elevated to expose the bone crest.
All incisions will be done using microsurgical ophthalmic blades. Buccal and lingual flaps will be elevated using sharp dissection only. Granulation tissue adherent to the inner surface of flaps will be carefully removed with microscissors to provide full access and visibility to root surfaces. Defect debridement and root planing will be performed with a combination of mini-curettes. Then sutures will be placed using 6-0 vicryl suture.
Postoperative medication:Administration of amoxicillin (500 mg tabs) T.I.D for 7 days), Chlorhexidine rinse (B.I.D for 14 days). Ibuprofen 600 mg tabs 1 every 8h in case of unbearable pain.
Patient self-care instructions: Sutures will be removed 2 weeks post-surgically. Patients will be asked to abstain from mechanical oral hygiene procedures in the surgical area for 2 weeks. After this period, patients will be instructed to continue mechanical tooth brushing again of the treated sites using a soft toothbrush.
The outcomes will be measured at 1 week, 3 and 6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Invasive Surgical Technique | Experimental | Procedure: Minimal invasive surgical technique |
| Open Flap Debridement | Active comparator | Procedure: Open Flap Debridement |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25 years of age or older.
- At least one periodontal infrabony pocket (detected radiographically) with Probing depth (PD) ≥5 mm,
- Plaque index < 30 %
Key exclusion criteria (6 listed)
- Hopeless tooth.
- Previous periodontal surgery within the last 2 years in area of interest.
- Systemic conditions which are generally considered to be a contraindication to periodontal surgery which included but not limited to: osteoporosis, uncontrolled diabetes.
- Pregnant or lactating females
- Current or former smokers.
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 |
|---|---|---|
| Minimal invasive surgical techniqueMinimal Invasive Surgical technique using either Modified Papilla Preservation or Simplified Papilla Preservation Technique. | Procedure or surgery | Minimal Invasive Surgical Technique |
| Open Flap DebridementBuccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect. | Procedure or surgery | Open Flap Debridement |
Primary outcome
Clinical Attachment Level
Time frame: up to 6 months post-operatively
It is the distance measured from the cemento-enamel junction (CEJ) to the bottom of the pocket.
4 secondary outcomes
Probing Depth
Time frame: up to 6 months post-operatively
Gingival Recession
Time frame: up to 6 months post-operatively
Post-Operative Pain
Time frame: up to 1 week post-operatively
Bone Fill
Time frame: up to 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Minimally Invasive Surgical Technique
RecruitingObservational study
High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes
Uveal Melanoma, High-risk Uveal Melanoma
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Active, not recruiting
Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures
Malignant Neoplasms, Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive surgical technique and Open Flap Debridement in people with Minimally Invasive Surgical Technique and Open Flap Debridement, run by Cairo University.
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 3 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Gamal Abd El Salam (00201223467565, Mohamed.gamaleldin@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: up to 6 months post-operatively). 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 27 Jun 2018.