Alveolar Bone LossPhase 3NCT03834649
Pontic Site Development Using Soft Tissue Augmentation
A Phase 3 study testing partially de-epithelized connective tissue graft and Mucograft in people with Alveolar Bone Loss, run by Nouran Abdulla Mater,MD at 1 site in Egypt.
Trial summary
in patients with vertical or horizontal defective of there ridge it is difficult to have prosthetic restoration with natural appearance emetating and simulating the adjacent abutment emergence profile so this study aims to develop the defective area using two different materials of soft tissue grafting techniques to… Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- partially de-epithelized connective tissue graft and Mucograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 25 Sep 2020
- Phase
- Phase 3
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single missing tooth and the patient decides to have fixed prosthesis as a treatment option for tooth replacement.
- Horizontal and\or vertical ridge defect at the pontic site
- Sufficient inter-arch distance.
- Restorable neighbouring abutments.
- Periodontally sound abutments.
- Skilled and motivated patient in maintaining good oral hygiene.
Who cannot join
- Multiple neighboring missing teeth.
- Systemic diseases that could affect treatment outcome.
- Poor oral hygiene.
- Patient is not motivated to have the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Soft Tissue Biotype and Volume Stability After Soft Tissue Augmentation by Using Mucograft® Versus Partially De-epithelized Connective Tissue Graft to Enhance the Pontic Site in Single Missing Tooth With Deficient Ridge: Randomized Clinical Trial
in patients with vertical or horizontal defective of there ridge it is difficult to have prosthetic restoration with natural appearance emetating and simulating the adjacent abutment emergence profile so this study aims to develop the defective area using two different materials of soft tissue grafting techniques to restore the missing tissue and regain soft tissue volume and profile
Read the detailed description
PICO P: single pontic site with deficient ridge. I: Soft tissue augmentation with partially de-epithelized connective tissue graft.
C: Soft tissue augmentation with Mucograft. O: Soft tissue biotype, Soft tissue volume, pain score and patient satisfaction.
Preoperative measures:
- All subjects will pass through phase I therapy (Supragingival scalling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
- After 4 weeks, all subjects will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash twice daily).
- Eligible patients will be randomized before being enrolled in the study. (T-1 +4 weeks)
- Study casts for case study will be fabricated and clinical photographs will be taken.
- Assessment of edentulous defect site and neighboring teeth will be performed by scanning the study casts.
Surgical phase (T0):
The same operator (N M) will perform all procedures under local anesthesia (4% articaine with 1/200 000 adrenaline Solution), using a local infiltration technique.
The recipient site will be prepared using 15c-blad creating a full-thickness coronal dissection and a partial thickness apical dissection creating a vestibular pouch.
The grafting procedure then performed and graft will be fixed by suturing at the periphery of the flap using 5/0 suture material and the rest will be inserted in the vestibular pouch.
The patient will have printed post-surgical instruction and precautions.
- Intervention for control group :
- The recipient site will be prepared with a full-thickness coronal dissection and a partial thickness apical dissection to creat a vestibular pouch.
- The acellular matrix (Mucograft®) will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch.
- Intervention for test group :
- The recipient site will be prepared with a full-thickness coronal dissection and a partial thickness apical dissection vestibular pouch.
- The graft which is composed of two parts:The coronal part, which is epithelialized
- The apical part, which is formed of connective tissue only.
- On the defect area, the crestal surface is de-epithelialized with a beveled incision and the apical surface is prepared with a partial-thickness dissection with two vertical- releasing incisions extended apically, without involving the adjacent papillae, in order to create a pouch area.
- The onlay section (epithelialized area) of the graft will be sutured on the crestal surface of the defect, while the inlay section (connective tissue) will be inserted and secured in the vestibular pouch area.
- Post-operative care:
As with any regenerative site, caution must be exercised in post-operative care and during oral hygiene practices at or near the surgical site. After 12 hours 875 mg of Amoxicillin and 125 mg of Clavulanic acid tablet (1 g Amoxicillin Clavulanate) twice daily for 7 days, anti-inflammatory tablet (Amphiltirne ) if the patient need ,maximum three times/day and chlorhexidine HCL 1.25% mouth wash mouthwash twice daily are prescribed. Sutures will be removed after 14 days. (12)
- Follow-up (T1, T2,T3): (T1):2 weeks post-operatively sutures removal . (T2) 3 months post-operatively appointments will be assigned for the prosthetic preparation and temporization for 2 weeks (T3): 6 months post-operatively appointments will be assigned for the prosthetic delivery and fill in the Questionnaire.
- Criteria for discontinuing intervention:
- Infection and sloughing of the graft.
- if the patient wouldn't commit to the follow-ups.
- Strategies to improve adherence to intervention protocol:
Patient preparation in terms of improving oral hygiene and first phase therapy procedures will be performed for patient to doctor trust. Complete information concerning the protocol will be provided and simplified to the patient with reasoning of all the steps included as the importance of the follow up visits and home medication.
Relevant concomitant care and interventions that are permitted or prohibited during the trial:
Postoperatively the patients will be using analgesics, oral antibiotic therapy, and chlorhexidine HCL 1.25% mouthwash mouthwash for at two week.
- Conditions
- Alveolar Bone Loss
- Being tested
- partially de-epithelized connective tissue graft, Mucograft
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partially de-epithelized connective tissue graftProcedure or surgery
Also called pontic site development, Combination onlay-inlay grafts
graft procedures to obtain simultaneous tissue augmentation in the horizontal and vertical dimensions. The donor site was prepared with a full-thickness coronal dissection and a partial-thickness apical dissection.The objectives were to use a single procedure to achieve simultaneously apico-coronal and buccolingual augmentation,to have a smaller open wound in the donor site and less patient discomfort, and to guarantee better revascularization of the onlay section aided by the submerged connective tissue section of the graft.
MucograftProcedure or surgery
Also called pontic site development, pre-prosthetic development
For preprosthetic defects, a standard mucosal augmentation procedure, which is well reported in the literature, was performed. The surgical site produced by the surgery leaves a "denuded area" supraperiosteally that is addressed by "grafting" with a xenogeneic collagen membrane (Mucograft).
purpose of the surgery is to improve the quantity of attached mucosa to facilitate the final dental reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Mucograft | Active comparator | Soft tissue augmentation of the defective alveolar ridge using Mucograft inside the prepared vestibular pouch leaving part of the mucograft exposed at the crestal area and will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch. Receives: Procedure: Mucograft |
| Partially de-epithelialized connective tissue graft | Experimental | Soft tissue augmentation of the defective alveolar ridge using Partially de-epithelialized connective tissue graft by preparing vestibular pouch at the defect site and place the de-epithelialized part inside the pouch leaving the epithelialized part sutured and exposed at the crestal area Receives: Procedure: partially de-epithelized connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
% of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.
Measured: 6 month
Secondary outcomes (1)
soft tissue stability (% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob)
% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Feb 2019 (estimated)
- Primary completion25 Aug 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nouran Abdulla Mater,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nouran Abdulla Mater,MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834649
- Sponsor's protocol ID
- 271188
- Status last verified
- Feb 2019
- First submitted
- 22 Jan 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Tissue Biotype and Volume Stability After Soft Tissue Augmentation by Using Mucograft® Versus Partially De-epithelized Connective Tissue Graft to Enhance the Pontic Site in Single Missing Tooth With Deficient Ridge: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03834649
- Acronym / sponsor ID
- 271188
- Conditions
- Alveolar Bone Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nouran Abdulla Mater,MDUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 25 Aug 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
in patients with vertical or horizontal defective of there ridge it is difficult to have prosthetic restoration with natural appearance emetating and simulating the adjacent abutment emergence profile so this study aims to develop the defective area using two different materials of soft tissue grafting techniques to restore the missing tissue and regain soft tissue volume and profile
Detailed description
PICO P: single pontic site with deficient ridge. I: Soft tissue augmentation with partially de-epithelized connective tissue graft.
C: Soft tissue augmentation with Mucograft. O: Soft tissue biotype, Soft tissue volume, pain score and patient satisfaction.
Preoperative measures:
- All subjects will pass through phase I therapy (Supragingival scalling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
- After 4 weeks, all subjects will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash twice daily).
- Eligible patients will be randomized before being enrolled in the study. (T-1 +4 weeks)
- Study casts for case study will be fabricated and clinical photographs will be taken.
- Assessment of edentulous defect site and neighboring teeth will be performed by scanning the study casts.
Surgical phase (T0):
The same operator (N M) will perform all procedures under local anesthesia (4% articaine with 1/200 000 adrenaline Solution), using a local infiltration technique.
The recipient site will be prepared using 15c-blad creating a full-thickness coronal dissection and a partial thickness apical dissection creating a vestibular pouch.
The grafting procedure then performed and graft will be fixed by suturing at the periphery of the flap using 5/0 suture material and the rest will be inserted in the vestibular pouch.
The patient will have printed post-surgical instruction and precautions.
- Intervention for control group :
- The recipient site will be prepared with a full-thickness coronal dissection and a partial thickness apical dissection to creat a vestibular pouch.
- The acellular matrix (Mucograft®) will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch.
- Intervention for test group :
- The recipient site will be prepared with a full-thickness coronal dissection and a partial thickness apical dissection vestibular pouch.
- The graft which is composed of two parts:The coronal part, which is epithelialized
- The apical part, which is formed of connective tissue only.
- On the defect area, the crestal surface is de-epithelialized with a beveled incision and the apical surface is prepared with a partial-thickness dissection with two vertical- releasing incisions extended apically, without involving the adjacent papillae, in order to create a pouch area.
- The onlay section (epithelialized area) of the graft will be sutured on the crestal surface of the defect, while the inlay section (connective tissue) will be inserted and secured in the vestibular pouch area.
- Post-operative care:
As with any regenerative site, caution must be exercised in post-operative care and during oral hygiene practices at or near the surgical site. After 12 hours 875 mg of Amoxicillin and 125 mg of Clavulanic acid tablet (1 g Amoxicillin Clavulanate) twice daily for 7 days, anti-inflammatory tablet (Amphiltirne ) if the patient need ,maximum three times/day and chlorhexidine HCL 1.25% mouth wash mouthwash twice daily are prescribed. Sutures will be removed after 14 days. (12)
- Follow-up (T1, T2,T3): (T1):2 weeks post-operatively sutures removal . (T2) 3 months post-operatively appointments will be assigned for the prosthetic preparation and temporization for 2 weeks (T3): 6 months post-operatively appointments will be assigned for the prosthetic delivery and fill in the Questionnaire.
- Criteria for discontinuing intervention:
- Infection and sloughing of the graft.
- if the patient wouldn't commit to the follow-ups.
- Strategies to improve adherence to intervention protocol:
Patient preparation in terms of improving oral hygiene and first phase therapy procedures will be performed for patient to doctor trust. Complete information concerning the protocol will be provided and simplified to the patient with reasoning of all the steps included as the importance of the follow up visits and home medication.
Relevant concomitant care and interventions that are permitted or prohibited during the trial:
Postoperatively the patients will be using analgesics, oral antibiotic therapy, and chlorhexidine HCL 1.25% mouthwash mouthwash for at two week.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucograft | Active comparator | Procedure: MucograftSoft tissue augmentation of the defective alveolar ridge using Mucograft inside the prepared vestibular pouch leaving part of the mucograft exposed at the crestal area and will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch. |
| Partially de-epithelialized connective tissue graft | Experimental | Procedure: partially de-epithelized connective tissue graftSoft tissue augmentation of the defective alveolar ridge using Partially de-epithelialized connective tissue graft by preparing vestibular pouch at the defect site and place the de-epithelialized part inside the pouch leaving the epithelialized part sutured and exposed at the crestal area |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Single missing tooth and the patient decides to have fixed prosthesis as a treatment option for tooth replacement.
- Horizontal and\or vertical ridge defect at the pontic site
- Sufficient inter-arch distance.
- Restorable neighbouring abutments.
- Periodontally sound abutments.
Key exclusion criteria (4 listed)
- Multiple neighboring missing teeth.
- Systemic diseases that could affect treatment outcome.
- Poor oral hygiene.
- Patient is not motivated to have the treatment.
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 |
|---|---|---|
| partially de-epithelized connective tissue graftAlso: pontic site development, Combination onlay-inlay graftsgraft procedures to obtain simultaneous tissue augmentation in the horizontal and vertical dimensions. The donor site was prepared with a full-thickness coronal dissection and a partial-thickness apical dissection.The objectives were to use a single procedure to achieve simultaneously apico-coronal and buccolingual augmentation,to have a smaller open wound in the donor site and less patient discomfort, and to guarantee better revascularization of the onlay section aided by the submerged connective tissue section of the graft. | Procedure or surgery | Partially de-epithelialized connective tissue graft |
| MucograftAlso: pontic site development, pre-prosthetic developmentFor preprosthetic defects, a standard mucosal augmentation procedure, which is well reported in the literature, was performed. The surgical site produced by the surgery leaves a "denuded area" supraperiosteally that is addressed by "grafting" with a xenogeneic collagen membrane (Mucograft). purpose of the surgery is to improve the quantity of attached mucosa to facilitate the final dental reconstruction | Procedure or surgery | Mucograft |
Primary outcome
Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
Time frame: 6 month
% of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.
1 secondary outcome
soft tissue stability (% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing partially de-epithelized connective tissue graft and Mucograft in people with Alveolar Bone Loss, run by Nouran Abdulla Mater,MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Nouran A Mater, Master holder (00201226953337, nouranmater133@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa) (time frame: 6 month). 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 11 Feb 2019.