Dental Implant PlacementNCT04310449
Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches With Immediate Implant Placement
A study testing Connective tissue graft and customized healing abutment and Dual zone concept and customized healing abutment in people with Dental Implant Placement, run by Misr International University at 2 sites in Egypt.
Trial summary
Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Placement
- What is being tested?
- Connective tissue graft and customized healing abutment and Dual zone concept and customized healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2020to 1 Feb 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
- Adults at or above the age of 18.
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
- Sagittal root position type 1 as described by Kan et al(30).
- Good oral hygiene
- Patient accepts to provide an informed consent.
Who cannot join
- Smokers
- Pregnant and lactating females.
- Medically compromised patients. , as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
International Dental Contining Education Centre (IDCE)
Cairo
Misr International University
Cairo
About this study
Official title: Hard and Soft Tissue Alterations on the Use of Dual Zone Concept Versus Connective Tissue Graft at Flapless Maxillary Immediate Implant Placement. A 1-year Randomized Clinical Trial and Volumetric Study.
Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9\&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.
Read the detailed description
After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. The allocation will be revealed to the principle investigator for the 3 implant groups after implant placement.
Group 1: extraction will occur and then followed by immediate implant placement,using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37). Particulate bone grafts are packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), Followed by customized healing abutment, the temporary cylindrical abutment twill be screwed to the implant and then flowable composite will be injected at the gingival margin level to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva, but will only seal the socket without extending deeper apically in the soft tissue. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque.
Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place, then will be covered by a customized healing abutment that will be done as mentioned before.
- Conditions
- Dental Implant Placement
- Being tested
- Connective tissue graft and customized healing abutment, Dual zone concept and customized healing abutment
- Keywords
- Immediate implant placement, Connective tissue graft, dual-zone therapeutic concept, customized healing abutment, buccal soft tissue contour, volumetric analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graft and customized healing abutmentProcedure or surgery
Also called zimmer biomed dental implants and connective tissue grafts and customized healing abutments
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.
Dual zone concept and customized healing abutmentProcedure or surgery
Also called zimmer biomed dental implants and dual zone bone grafting and customized healing abutments
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| Dual zone concept and customized healing abutment | Experimental | Immediate implant placement with bone grafts in the dual zone and customized healing abutment. Receives: Procedure: Dual zone concept and customized healing abutment |
| Connective tissue graft and customized healing abutment | Active comparator | immediate implant placement with CTG and customized healing abutment Receives: Procedure: Connective tissue graft and customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score (PES)
The PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points. The grading using the PES suggested by Fürhauser will be performed. The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value (Fürhauser et al., 2005).
Measured: 6 months after delivery (18 months after IIP)
Secondary outcomes (8)
Bucco-palatal width
Measured with CBCT
Measured: Before surgery - 12 months
Gingival thickness
Measured with periodontal probe
Measured: Before surgery - 6 months - 12 months
Mid facial recession to assess the changes in tissue level
Measured with 3D Viewer software
Measured: Before surgery - 3 months - 6 months - 9 months - 12 months
Interdental papillae height to assess changes in papilla height
Measured with 3D Viewer software
Measured: Before surgery - 3 months - 6 months - 9 months - 12 months
Modified Plaque Index
Measured with Periodontal probe
Measured: 3 months - 6 months - 9 months - 12 months
Modified Bleeding Index
Measured with Periodontal probe
Measured: 3 months - 6 months - 9 months - 12 months
Patient satisfaction
Measured with Visual Analogue Scale (VAS). The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant
Measured: 12 months
Volumetric analysis of buccal contour to assess changes in buccal countour
Measured with Extra oral scanning + 3D viewer software
Measured: Before surgery - 3 months - 6 months - 9 months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jul 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Dental Implant PlacementStudies of the same condition, open and under way.
- 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
- Model description
- • To compare the volumetric changes in the buccal soft tissue contour between immediate implants with CTG and customized healing abutments, and immediate implants with bone grafting in the dual zone and customized healing abutmnets
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, Misr International University
- Investigators
- Ahmed I Abo El Futtouh, Master, Principal investigator, Clinical Director of Implant Program - Misr International UniversityKhaled Abdel-Ghaffar, Professor, Study director, Minister of Higher Education and Scientific ResearchInas S Hanna, Bsc, Study director, Dentist/Researcher - IDCENael A Mina, Bsc, Study chair, Misr International UniversityAbdel Rahman A Abdel Rahman, Master, Study chair, International Dental Contiuing EducationAhmed F Mostafa, Bsc, Study chair, International Dental Contiuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310449
- Sponsor's protocol ID
- PER8273002
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared
Publications
Gluckman H, Salama M, Du Toit J. Partial Extraction Therapies (PET) Part 2: Procedures and Technical Aspects. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):377-385. doi: 10.11607/prd.3111.
PubMed 28402349Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26.
PubMed 25434568Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. The efficacy of horizontal and vertical bone augmentation procedures for dental implants - a Cochrane systematic review. Eur J Oral Implantol. 2009 Autumn;2(3):167-84.
PubMed 20467628Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
PubMed 24660198Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
PubMed 15635945Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
PubMed 15839587Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.
PubMed 17092218Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
PubMed 19885446Horvath A, Mardas N, Mezzomo LA, Needleman IG, Donos N. Alveolar ridge preservation. A systematic review. Clin Oral Investig. 2013 Mar;17(2):341-63. doi: 10.1007/s00784-012-0758-5. Epub 2012 Jul 20.
PubMed 22814758Masaki C, Nakamoto T, Mukaibo T, Kondo Y, Hosokawa R. Strategies for alveolar ridge reconstruction and preservation for implant therapy. J Prosthodont Res. 2015 Oct;59(4):220-8. doi: 10.1016/j.jpor.2015.04.005. Epub 2015 May 26.
PubMed 26022542De Risi V, Clementini M, Vittorini G, Mannocci A, De Sanctis M. Alveolar ridge preservation techniques: a systematic review and meta-analysis of histological and histomorphometrical data. Clin Oral Implants Res. 2015 Jan;26(1):50-68. doi: 10.1111/clr.12288. Epub 2013 Nov 1.
PubMed 27007188Luckerath W, Roder L, Enkling N. The Effect of Primary Stabilization of the Graft in a Combined Surgical and Prosthodontic Ridge Preservation Protocol: A Prospective Controlled Clinical Pilot Study. Int J Periodontics Restorative Dent. 2018 May/Jun;38(3):e49-e58. doi: 10.11607/prd.3172.
PubMed 29641631Kan JY, Rungcharassaeng K. Immediate placement and provisionalization of maxillary anterior single implants: a surgical and prosthodontic rationale. Pract Periodontics Aesthet Dent. 2000 Nov-Dec;12(9):817-24; quiz 826.
PubMed 11405020Kan JYK, Rungcharassaeng K, Deflorian M, Weinstein T, Wang HL, Testori T. Immediate implant placement and provisionalization of maxillary anterior single implants. Periodontol 2000. 2018 Jun;77(1):197-212. doi: 10.1111/prd.12212. Epub 2018 Feb 25.
PubMed 29478284
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hard and Soft Tissue Alterations on the Use of Dual Zone Concept Versus Connective Tissue Graft at Flapless Maxillary Immediate Implant Placement. A 1-year Randomized Clinical Trial and Volumetric Study.
- ClinicalTrials.gov ID
- NCT04310449
- Acronym / sponsor ID
- PER8273002
- Conditions
- Dental Implant Placement
- Keywords
- Immediate implant placement, Connective tissue graft, dual-zone therapeutic concept, customized healing abutment, buccal soft tissue contour, volumetric analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 Mar 2020 (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.
Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9\&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.
Detailed description
After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. The allocation will be revealed to the principle investigator for the 3 implant groups after implant placement.
Group 1: extraction will occur and then followed by immediate implant placement,using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37). Particulate bone grafts are packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), Followed by customized healing abutment, the temporary cylindrical abutment twill be screwed to the implant and then flowable composite will be injected at the gingival margin level to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva, but will only seal the socket without extending deeper apically in the soft tissue. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque.
Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place, then will be covered by a customized healing abutment that will be done as mentioned before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- • To compare the volumetric changes in the buccal soft tissue contour between immediate implants with CTG and customized healing abutments, and immediate implants with bone grafting in the dual zone and customized healing abutmnets
| Arm | Type | Receives |
|---|---|---|
| Dual zone concept and customized healing abutment | Experimental | Procedure: Dual zone concept and customized healing abutmentImmediate implant placement with bone grafts in the dual zone and customized healing abutment. |
| Connective tissue graft and customized healing abutment | Active comparator | Procedure: Connective tissue graft and customized healing abutmentimmediate implant placement with CTG and customized healing abutment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
- Adults at or above the age of 18.
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
- Sagittal root position type 1 as described by Kan et al(30).
Key exclusion criteria (6 listed)
- Smokers
- Pregnant and lactating females.
- Medically compromised patients. , as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
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 |
|---|---|---|
| Connective tissue graft and customized healing abutmentAlso: zimmer biomed dental implants and connective tissue grafts and customized healing abutmentsImmediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant. | Procedure or surgery | Connective tissue graft and customized healing abutment |
| Dual zone concept and customized healing abutmentAlso: zimmer biomed dental implants and dual zone bone grafting and customized healing abutmentsImmediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment. | Procedure or surgery | Dual zone concept and customized healing abutment |
Primary outcome
Pink Esthetic Score (PES)
Time frame: 6 months after delivery (18 months after IIP)
The PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points. The grading using the PES suggested by Fürhauser will be performed. The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value (Fürhauser et al., 2005).
8 secondary outcomes
Bucco-palatal width
Time frame: Before surgery - 12 months
Gingival thickness
Time frame: Before surgery - 6 months - 12 months
Mid facial recession to assess the changes in tissue level
Time frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Interdental papillae height to assess changes in papilla height
Time frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Modified Plaque Index
Time frame: 3 months - 6 months - 9 months - 12 months
Modified Bleeding Index
Time frame: 3 months - 6 months - 9 months - 12 months
Patient satisfaction
Time frame: 12 months
Volumetric analysis of buccal contour to assess changes in buccal countour
Time frame: Before surgery - 3 months - 6 months - 9 months - 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 21 Nov 2024.
- Results publication: PubMed 28402349Gluckman H, Salama M, Du Toit J. Partial Extraction Therapies (PET) Part 2: Procedures and Technical Aspects. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):377-385. doi: 10.11607/prd.3111.
- Results publication: PubMed 25434568Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26.
- Results publication: PubMed 20467628Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. The efficacy of horizontal and vertical bone augmentation procedures for dental implants - a Cochrane systematic review. Eur J Oral Implantol. 2009 Autumn;2(3):167-84.
- Results publication: PubMed 24660198Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
- Results publication: PubMed 15635945Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
- Results publication: PubMed 15839587Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
- Results publication: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Results publication: PubMed 17092218Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.
- Results publication: PubMed 19885446Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
- Results publication: PubMed 22814758Horvath A, Mardas N, Mezzomo LA, Needleman IG, Donos N. Alveolar ridge preservation. A systematic review. Clin Oral Investig. 2013 Mar;17(2):341-63. doi: 10.1007/s00784-012-0758-5. Epub 2012 Jul 20.
- Results publication: PubMed 26022542Masaki C, Nakamoto T, Mukaibo T, Kondo Y, Hosokawa R. Strategies for alveolar ridge reconstruction and preservation for implant therapy. J Prosthodont Res. 2015 Oct;59(4):220-8. doi: 10.1016/j.jpor.2015.04.005. Epub 2015 May 26.
- Results publication: PubMed 27007188De Risi V, Clementini M, Vittorini G, Mannocci A, De Sanctis M. Alveolar ridge preservation techniques: a systematic review and meta-analysis of histological and histomorphometrical data. Clin Oral Implants Res. 2015 Jan;26(1):50-68. doi: 10.1111/clr.12288. Epub 2013 Nov 1.
- Individual participant dataSharing planned: Yes. All data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed I Abo El Futtouh, Master principal investigator
Clinical Director of Implant Program - Misr International University
Khaled Abdel-Ghaffar, Professor study director
Minister of Higher Education and Scientific Research
Inas S Hanna, Bsc study director
Dentist/Researcher - IDCE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft and customized healing abutment and Dual zone concept and customized healing abutment in people with Dental Implant Placement, run by Misr International University at 2 sites 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 7 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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pink Esthetic Score (PES) (time frame: 6 months after delivery (18 months after IIP)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310449, which also lists 24 linked publications.
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 21 Nov 2024.