Intrabony Periodontal DefectPhase 4NCT06048042
Evaluation of Autogenous Demineralized Dentin Graft Vs Autogenous Bone Graft in Management of Intrabony Defects
A Phase 4 study testing Autogenous Demineralized Dentin Graft and Autogenous Bone Graft in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
Trial summary
The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Autogenous Demineralized Dentin Graft and Autogenous Bone Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jul 2024to Mar 2025
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient-related criteria:
- Motivated patient 18 years of age or order.
- Patient consulting in the outpatient clinic.
- Patient ready to perform oral hygiene instructions.
- Provide informed consent.
- Accepts the 6 months follow-up period.
Show all 10Show fewer
- Teeth related criteria:
- Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
- Mature permanent tooth.
- Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.
Who cannot join
- Patient-related criteria:
- Medically compromised patients.
- Pregnant women.
- Uncooperative patients.
- Smokers.
- Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).
Show all 13Show fewer
- Failure to maintain good oral hygiene.
- Teeth related criteria:
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
- Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
- Presence of caries or overhanging restorations.
- Presence of peri-apical injuries.
Trial locations and contacts
1 site in 1 country.
Nesma Shemais, Ass Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
About this study
Official title: Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft Versus Autogenous Bone Graft in Management of Periodontal Intrabony Defects Using Modified Minimally Invasive Surgical Technique: A Non-Randomized Clinical Trial
The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.
The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.
Read more
After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.
Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm.
Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST).
Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth.
Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area.
For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.
Read the detailed description
Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective therapeutic approaches that help in management of periodontal intrabony defects. Due to the shortcomings of other bone substitute materials, another bone substitute material that would be completely autogenous and cost-effective is required. Grafting autogenous demineralized dentin has been used extensively for socket preservation and showed promising results in addition to being cost-effective.
Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
- Inclusion criteria:
Patient-related criteria:
- Motivated patient 18 years of age or order.
- Patient consulting in the outpatient clinic.
- Patient ready to perform oral hygiene instructions.
- Provide informed consent.
- Accepts the 6 months follow-up period.
Teeth related criteria:
- Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
- Mature permanent tooth.
- Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.
II. Exclusion criteria:
Patient-related criteria:
- Medically compromised patients.
- Pregnant women.
- Uncooperative patients.
- Smokers.
- Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).
- Failure to maintain good oral hygiene.
Teeth related criteria:
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
- Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
- Presence of caries or overhanging restorations.
- Presence of peri-apical injuries.
General operative procedure:
- The selected participants will be informed about the nature of the research and its procedures, then written informed consent will be obtained.
- The surgical procedure will be explained to all patients prior to surgery.
- Patients diagnosed with periodontitis who meet the inclusion criteria will be screened for periodontal examination. Based on this examination, target sites will be identified.
- Each patient will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.
Pre-surgical patient preparation (Re-evaluation phase):
- 4-6 weeks after the initial therapy, periodontal re-evaluation will be done to confirm the sites that will require surgical therapy.
- Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD ≥ 5 mm, CAL ≥ 4 mm.
- An individually customized positioning stent will be fabricated for each patient and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.
- A periapical radiograph using paralleling technique using KCP film holder will be performed for each patient to evaluate alveolar bone loss using DIGORA system.
Surgical procedures
- Pre-procedural mouth rinse using 0.2% chlorhexidine gluconate3 rinses for intraoral antisepsis.
- Surgical sites will be anaesthetized using local anesthesia4.
- The defect-associated inter-dental papilla will be surgically approached either with a diagonal incision following the pattern of the simplified papilla preservation flap when the width of the inter-dental space is 2 mm or narrower or with a horizontal incision according to the modified papilla preservation technique at inter-dental sites wider than 2 mm.
- Flap elevation will be limited to the buccal flap.
- No inter-dental and/or lingual intra-sulcular incisions will be performed.
- After removal of the granulation tissue by careful dissection and root debridement, the root surface will be chemically conditioned with a 2 min. application of an EDTA gel.
The participants will be divided into two groups:
Intervention group:
- The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.
Control group:
- Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect.
- For both groups, flaps will be approximated and sutured at the original position with a 5-0 monofilament polypropylene suture material using simple direct loop interrupted technique.
Post-operative care and follow-up
- Participants will be instructed to abstain from trauma on the operative site, not to interfere with the suture and to avoid hot food or vigorous rinsing.
- Tooth brushing will be encouraged for other parts of the dentition and gentle tooth brushing for the operative site will be advised to be resumed after two weeks.
- Participants will be prescribed Ibuprofen 600 mg.
- Chlorhexidine 0.12% mouthwash will be prescribed for gentle rinsing twice daily for two weeks.
- Sutures will be removed two weeks after the surgery.
- All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Autogenous Demineralized Dentin Graft, Autogenous Bone Graft
- Keywords
- Intrabony Periodontal Defect, Demineralized dentin graft, Autogenous bone graft, modified minimally invasive surgical technique, M-MIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous Demineralized Dentin GraftBiological
The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.
Autogenous Bone GraftBiological
Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Demineralized Dentin Graft | Experimental | An Autogenous Demineralized Dentin Graft will be prepared from the participant's freshly extracted teeth and placed in the intrabony defect following the modified minimally invasive surgical technique. Receives: Biological: Autogenous Demineralized Dentin Graft |
| Autogenous bone Graft | Active comparator | An Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique. Receives: Biological: Autogenous Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL) gain change from baseline to 6 months.
The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.
Measured: CAL gain will be taken at baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Secondary outcomes (8)
Linear bone fill change from baseline to 6 months
Linear bone fill will be radiographically measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software. Individually customized positioning stent will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. This will ensure accuracy and reproducibility of the measurements. Radiographic linear defect depth (RLDD) will be measured as the depth of the intrabony defect from the alveolar crest to the defect base at baseline and 6 months postoperatively. The defect angle will be measured at baseline, as the angle formed between intersections of lines from the alveolar crest to the defect base and tooth long axis line. Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values, and percentages of bone fill will be expressed as the proportion of change to baseline RLDD.
Measured: Linear bone fill will be measured at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Gingival index (GI) change from baseline to 6 months
The GI will be evaluated by using Silness-Loe GI (0 = Normal gingiva, 1 = Mild inflammation, 2 = Moderate inflammation, 3 = Severe inflammation).
Measured: GI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Plaque index (PI) change from baseline to 6 months
The PI will be evaluated by using Silness-Loe PI (0 = no plaque, 1 = thin film of plaque along the gingival margin, 2 = Moderate accumulation of plaque in the sulcus, 3 = Large amount of plaque in sulcus along the gingival margin).
Measured: PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Probing pocket depth (PPD) change from baseline to 6 months
The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.
Measured: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Gingival recession (GR) change from baseline to 6 months
The GR will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.
Measured: GR will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Bleeding on probing (BoP) change from baseline to 6 months
The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.
Measured: BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Postoperative Pain
Postoperative Pain will be measured by using visual analogue score (0-10).
Measured: Postoperative Pain will be measured after the surgical procedure and 2 weeks post-surgical.
Patient satisfaction
Patient satisfaction will be measured using a survey.
Measured: Patient satisfaction will be measured 2 weeks post-surgical.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Jul 2024
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A non-randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Ali Hussein Abouhussein, Cairo University
- Investigators
- Ghada M. Abouhussein, Bachelor, Principal investigator, Cairo UniversityWeam El-Battawy, Ass professor, Study director, Cairo UniversityNesma Shemais, Ass lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048042
- Sponsor's protocol ID
- ghadashatra123
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2023
- Last updated
- 26 Aug 2024
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft Versus Autogenous Bone Graft in Management of Periodontal Intrabony Defects Using Modified Minimally Invasive Surgical Technique: A Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06048042
- Acronym / sponsor ID
- ghadashatra123
- Conditions
- Intrabony Periodontal Defect
- Keywords
- Intrabony Periodontal Defect, Demineralized dentin graft, Autogenous bone graft, modified minimally invasive surgical technique, M-MIST
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 21 Sep 2023 (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 main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.
The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.
After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.
Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm.
Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST).
Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth.
Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area.
For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.
Detailed description
Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective therapeutic approaches that help in management of periodontal intrabony defects. Due to the shortcomings of other bone substitute materials, another bone substitute material that would be completely autogenous and cost-effective is required. Grafting autogenous demineralized dentin has been used extensively for socket preservation and showed promising results in addition to being cost-effective.
Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
- Inclusion criteria:
Patient-related criteria:
- Motivated patient 18 years of age or order.
- Patient consulting in the outpatient clinic.
- Patient ready to perform oral hygiene instructions.
- Provide informed consent.
- Accepts the 6 months follow-up period.
Teeth related criteria:
- Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
- Mature permanent tooth.
- Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.
II. Exclusion criteria:
Patient-related criteria:
- Medically compromised patients.
- Pregnant women.
- Uncooperative patients.
- Smokers.
- Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).
- Failure to maintain good oral hygiene.
Teeth related criteria:
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
- Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
- Presence of caries or overhanging restorations.
- Presence of peri-apical injuries.
General operative procedure:
- The selected participants will be informed about the nature of the research and its procedures, then written informed consent will be obtained.
- The surgical procedure will be explained to all patients prior to surgery.
- Patients diagnosed with periodontitis who meet the inclusion criteria will be screened for periodontal examination. Based on this examination, target sites will be identified.
- Each patient will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.
Pre-surgical patient preparation (Re-evaluation phase):
- 4-6 weeks after the initial therapy, periodontal re-evaluation will be done to confirm the sites that will require surgical therapy.
- Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD ≥ 5 mm, CAL ≥ 4 mm.
- An individually customized positioning stent will be fabricated for each patient and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.
- A periapical radiograph using paralleling technique using KCP film holder will be performed for each patient to evaluate alveolar bone loss using DIGORA system.
Surgical procedures
- Pre-procedural mouth rinse using 0.2% chlorhexidine gluconate3 rinses for intraoral antisepsis.
- Surgical sites will be anaesthetized using local anesthesia4.
- The defect-associated inter-dental papilla will be surgically approached either with a diagonal incision following the pattern of the simplified papilla preservation flap when the width of the inter-dental space is 2 mm or narrower or with a horizontal incision according to the modified papilla preservation technique at inter-dental sites wider than 2 mm.
- Flap elevation will be limited to the buccal flap.
- No inter-dental and/or lingual intra-sulcular incisions will be performed.
- After removal of the granulation tissue by careful dissection and root debridement, the root surface will be chemically conditioned with a 2 min. application of an EDTA gel.
The participants will be divided into two groups:
Intervention group:
- The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.
Control group:
- Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect.
- For both groups, flaps will be approximated and sutured at the original position with a 5-0 monofilament polypropylene suture material using simple direct loop interrupted technique.
Post-operative care and follow-up
- Participants will be instructed to abstain from trauma on the operative site, not to interfere with the suture and to avoid hot food or vigorous rinsing.
- Tooth brushing will be encouraged for other parts of the dentition and gentle tooth brushing for the operative site will be advised to be resumed after two weeks.
- Participants will be prescribed Ibuprofen 600 mg.
- Chlorhexidine 0.12% mouthwash will be prescribed for gentle rinsing twice daily for two weeks.
- Sutures will be removed two weeks after the surgery.
- All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A non-randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Autogenous Demineralized Dentin Graft | Experimental | Biological: Autogenous Demineralized Dentin GraftAn Autogenous Demineralized Dentin Graft will be prepared from the participant's freshly extracted teeth and placed in the intrabony defect following the modified minimally invasive surgical technique. |
| Autogenous bone Graft | Active comparator | Biological: Autogenous Bone GraftAn Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient-related criteria:
- Teeth related criteria:
Key exclusion criteria (13 listed)
- Patient-related criteria:
- Teeth related criteria:
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 |
|---|---|---|
| Autogenous Demineralized Dentin GraftThe participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique. | Biological | Autogenous Demineralized Dentin Graft |
| Autogenous Bone GraftModified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect. | Biological | Autogenous bone Graft |
Primary outcome
Clinical attachment level (CAL) gain change from baseline to 6 months.
Time frame: CAL gain will be taken at baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.
The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.
8 secondary outcomes
Linear bone fill change from baseline to 6 months
Time frame: Linear bone fill will be measured at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Gingival index (GI) change from baseline to 6 months
Time frame: GI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Plaque index (PI) change from baseline to 6 months
Time frame: PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Probing pocket depth (PPD) change from baseline to 6 months
Time frame: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Gingival recession (GR) change from baseline to 6 months
Time frame: GR will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Bleeding on probing (BoP) change from baseline to 6 months
Time frame: BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Postoperative Pain
Time frame: Postoperative Pain will be measured after the surgical procedure and 2 weeks post-surgical.
Patient satisfaction
Time frame: Patient satisfaction will be measured 2 weeks post-surgical.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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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.
Nesma Shemais, Ass Lecturer contact
Ghada M. Abouhussein, Bachelor principal investigator
Cairo University
Weam El-Battawy, Ass professor study director
Cairo University
Nesma Shemais, Ass lecturer study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autogenous Demineralized Dentin Graft and Autogenous Bone Graft 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 10 inclusion and 13 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 26 Aug 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ghada M. Abouhussein, Bachelor (+02 01004966156, ghada.mohammed@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 (CAL) gain change from baseline to 6 months. (time frame: CAL gain will be taken at baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.). 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 26 Aug 2024.