Soft Tissue Augmentation Around Dental ImplantsNCT06479733
Evaluation of Buccal Pedicle Flap, Connective Tissue Graft and Acellular Dermal Matrix for Volumetric Augmentation of Peri-implant Mucosa
A study testing buccal pedicle flap, connective tissue graft and acellular dermal matrix in people with Soft Tissue Augmentation Around Dental Implants, run by Ghada Elhusseiny at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the efficacy of different soft tissue grafting techniques including buccal pedicle flap alone, free connective tissue graft and acellular dermal matrix for volumetric augmentation of peri-implant mucosa during the second stage implant surgery. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation Around Dental Implants
- What is being tested?
- buccal pedicle flap, connective tissue graft and acellular dermal matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient age : above 20 years with single or multiple edentulous spaces
- Healthy periodontium.
- Thin periodontal phenotype.
- Non smoker.
- Adequate amount of basal bone to achieve primary stability.
- Patient who is able to understand and sign a written consent.
- Patient with good oral hygiene measures and plaque index<1
Who cannot join
- • Presence of systemic , local disease or any medication that would compromise healing.
- Presence of infection or pathology related to the surgical area.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the efficacy of different soft tissue grafting techniques including buccal pedicle flap alone, free connective tissue graft and acellular dermal matrix for volumetric augmentation of peri-implant mucosa during the second stage implant surgery.
Read the detailed description
Soft tissue grafting around dental implants has been recommended to enhance functional, biological, and esthetic outcomes. As a thick peri-implant mucosa is of importance to prevent recession, color alterations, bone remodeling and promote "creeping attachment". Two major indications include the increase of the KM width and the increase of soft tissue volume using autogenous or alternative type grafts.
Several techniques have been proposed to augment the volume of the mucosa to achieve the so-called pink esthetics: connective tissue grafts, lyophilized allogenic soft tissue grafts, porcine collagen matrix, free gingival grafts, a combination of grafting and vestibuloplasty, strip gingival autografts, tissue engineered fibroblasts, allograft, collagen matrices, and the use of the buccal pedicle flap.
Among surgical techniques, the proposed modified buccal pedicle flap was demonstrated to perform well in terms of decreased morbidity, maintenance of blood supply, stabilization of the pedicle, superior haemostasis, and speed of treatment. However, a possible drawback may be related to the original thickness of the flap since a thin mucosa phenotype may be more prompt to perforation when in contact with a cross-linked collagen matrix.
The autologous subepithelial connective tissue graft (sCTG) is generally regarded as the gold standard for soft tissue augmentation around natural teeth and dental implants. However, harvesting an autologous soft tissue graft necessarily entails additional preoperative preparation, a second surgical site, longer operative duration, and increased morbidity, regardless of the surgical technique employed and the expertise of the operator.
Another alternative for autogenous grafting is the acellular dermal matrix (ADM) allograft that is derived from human skin. ADM, originally used for treating burn wounds , is an epithelium free, freeze-dried matrix containing types I and III collagen bundles where elastic fibers are its main components . ADM acts as a bioactive scaffold that integrates in host tissue and permits the migration of fibroblasts and epithelial and endothelial cells through vascular channels of the recipient sites . Since its initial use, ADM has been widely used in dental practice, in particular for soft tissue grafting of gingival recession or to change the quality of peri-implant/teeth mucosa.
- Being tested
- buccal pedicle flap, connective tissue graft, acellular dermal matrix, control group
- Keywords
- soft tissue, augmentation, dental implants, connective tissue graft, alloderm, buccal pedicle flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal pedicle flapProcedure or surgery
For the first group (buccal pedicle flap group), outlining the full-thickness palatal flap 1 mm greater than the diameter of the underlying cover screw will be done, making a partial incision at the hinge portion of the created mini-pedicle flap to facilitate buccal rolling, de-epithelializing the mini-pedicle flap, then two small vertical incisions will be performed similarly mesial and distal to the screw border as wide as possible preserving the papilla and extending labially to include all the keratinized mucosa, elevating a full-thickness flap, then rolling of the pedicle flap into the created buccal pouch. The flap will be then sutured all around in place using a 5/0 vicryl suture
connective tissue graftProcedure or surgery
For the second group (free CTG group), masticatory mucosa on the palate between palatal raphae and maxillary posterior teeth is the most common location for the donor site for free CTG. It will be obtained by harvesting and de-epithelializing FGG asbeing a CTG derived from de-epithelialization of FGG mainly composed of lamina propria. Then the donor site will be covered by gel foam , sutured and protected.
acellular dermal matrixProcedure or surgery
- For the third group (ADM group) , The matrix will be trimmed so that it is gently adapted to the artificial envelope created on the buccal aspect of the ridge.The matrix will be trimmed and beveled to make its adaptation into the artificial envelope easier. Before placement, matrix will be hydrated for 10 minutes in fresh human blood collected after flap elevation in each patient.
- For both second and third groups, graft will be carefully positioned under the buccal pouch, sutured to it, light pressure will be applied over the inserted graft with moist gauze for 10 minutes to minimize blood clot and dead space formation between the graft and the underlying bone.
control groupProcedure or surgery
only placement of dental implant without soft tissue augmentation
| Study group | Role | What they receive |
|---|---|---|
| Group I (buccal pedicle flap group): | Active comparator | Includes 7 implants that will receive implants with soft tissue augmentation using buccal pedicle flap only. Receives: Procedure: buccal pedicle flap |
| Group II (free CTG group): | Active comparator | Includes 7 implants that will receive implants with soft tissue augmentation using free CTG. Receives: Procedure: connective tissue graft |
| Group III (ADM group): | Active comparator | Includes 7 implants that will receive implants with soft tissue augmentation using acellular dermal matrix. Receives: Procedure: acellular dermal matrix |
| Group IV (control group): | Sham comparator | Includes 7 implants that will receive implants without soft tissue augmentation. Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measurement of soft tissue thickness
At the baseline surgical visit, after local anesthetic administeration, the buccal peri-implant mucosal thickness (PMT) will be measured and recorded. An endodontic spreader will be gently inserted through the the surface of the mucosa to the bone, then the thickness measured by the spreader will be recorded using a digital caliper. The procedure will be reapeated after complete healing of the tissue
Measured: 6 months
Esthetic evaluation
According to Furhauser et al., 2005, esthetic scoring index called pink esthetic score (PES) index will be used in the current study. Seven points of evaluation (mesial papilla, distal papilla, soft tissue margins, soft tissue contouring, alveolar process, soft tissue color and soft tissue texture) of score 0,1,2: this index uses a maximum score of 14, representing optimum esthetic outcome with respect to the peri-implant soft tissue conditions. The PES index fulfilled important characteristics as inclusion of the peri-implant soft tissue and the restoration-inherent parameters.
Measured: 6 months
Secondary outcomes (2)
modified gingival index
Lobene developed the Modified Gingival Index (MGI), which changed the criteria of the Gingival Index by using a non-invasive (no probing) method and resetting the rating for mild and moderate inflammation. The following criteria are used in this manner:
0 = absence of inflammation;
- = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary;
- = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary;
- = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary;
- = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.
Measured: 6 months
modified plaque index
The modified plaque index was calculated using the approach reported by Mombelli et al. for plaque scoring as follows: Plaque was scored 0 if no plaque was detected, 1 if plaque was detected only by running a probe across a smooth surface of the abutment/implant, 2 if plaque cloud could be seen with the naked eye, and 3 if there was an abundance of soft matter.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jun 2023
- Primary completion15 May 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Augmentation Around Dental ImplantsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghada Elhusseiny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ghada Elhusseiny, Mansoura University
- Investigators
- Ghada A. Elhusseiny, PHD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479733
- Sponsor's protocol ID
- A02060722
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Buccal Pedicle Flap, Connective Tissue Graft and Acellular Dermal Matrix for Volumetric Augmentation of Peri-implant Mucosa
- ClinicalTrials.gov ID
- NCT06479733
- Acronym / sponsor ID
- A02060722
- Keywords
- soft tissue, augmentation, dental implants, connective tissue graft, alloderm, buccal pedicle flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ghada ElhusseinyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 28 Jun 2024 (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 aim of the study is to evaluate the efficacy of different soft tissue grafting techniques including buccal pedicle flap alone, free connective tissue graft and acellular dermal matrix for volumetric augmentation of peri-implant mucosa during the second stage implant surgery.
Detailed description
Soft tissue grafting around dental implants has been recommended to enhance functional, biological, and esthetic outcomes. As a thick peri-implant mucosa is of importance to prevent recession, color alterations, bone remodeling and promote "creeping attachment". Two major indications include the increase of the KM width and the increase of soft tissue volume using autogenous or alternative type grafts.
Several techniques have been proposed to augment the volume of the mucosa to achieve the so-called pink esthetics: connective tissue grafts, lyophilized allogenic soft tissue grafts, porcine collagen matrix, free gingival grafts, a combination of grafting and vestibuloplasty, strip gingival autografts, tissue engineered fibroblasts, allograft, collagen matrices, and the use of the buccal pedicle flap.
Among surgical techniques, the proposed modified buccal pedicle flap was demonstrated to perform well in terms of decreased morbidity, maintenance of blood supply, stabilization of the pedicle, superior haemostasis, and speed of treatment. However, a possible drawback may be related to the original thickness of the flap since a thin mucosa phenotype may be more prompt to perforation when in contact with a cross-linked collagen matrix.
The autologous subepithelial connective tissue graft (sCTG) is generally regarded as the gold standard for soft tissue augmentation around natural teeth and dental implants. However, harvesting an autologous soft tissue graft necessarily entails additional preoperative preparation, a second surgical site, longer operative duration, and increased morbidity, regardless of the surgical technique employed and the expertise of the operator.
Another alternative for autogenous grafting is the acellular dermal matrix (ADM) allograft that is derived from human skin. ADM, originally used for treating burn wounds , is an epithelium free, freeze-dried matrix containing types I and III collagen bundles where elastic fibers are its main components . ADM acts as a bioactive scaffold that integrates in host tissue and permits the migration of fibroblasts and epithelial and endothelial cells through vascular channels of the recipient sites . Since its initial use, ADM has been widely used in dental practice, in particular for soft tissue grafting of gingival recession or to change the quality of peri-implant/teeth mucosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (buccal pedicle flap group): | Active comparator | Procedure: buccal pedicle flapIncludes 7 implants that will receive implants with soft tissue augmentation using buccal pedicle flap only. |
| Group II (free CTG group): | Active comparator | Procedure: connective tissue graftIncludes 7 implants that will receive implants with soft tissue augmentation using free CTG. |
| Group III (ADM group): | Active comparator | Procedure: acellular dermal matrixIncludes 7 implants that will receive implants with soft tissue augmentation using acellular dermal matrix. |
| Group IV (control group): | Sham comparator | Procedure: control groupIncludes 7 implants that will receive implants without soft tissue augmentation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age : above 20 years with single or multiple edentulous spaces
- Healthy periodontium.
- Thin periodontal phenotype.
- Non smoker.
- Adequate amount of basal bone to achieve primary stability.
Key exclusion criteria (3 listed)
- • Presence of systemic , local disease or any medication that would compromise healing.
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 |
|---|---|---|
| buccal pedicle flapFor the first group (buccal pedicle flap group), outlining the full-thickness palatal flap 1 mm greater than the diameter of the underlying cover screw will be done, making a partial incision at the hinge portion of the created mini-pedicle flap to facilitate buccal rolling, de-epithelializing the mini-pedicle flap, then two small vertical incisions will be performed similarly mesial and distal to the screw border as wide as possible preserving the papilla and extending labially to include all the keratinized mucosa, elevating a full-thickness flap, then rolling of the pedicle flap into the created buccal pouch. The flap will be then sutured all around in place using a 5/0 vicryl suture | Procedure or surgery | Group I (buccal pedicle flap group): |
| connective tissue graftFor the second group (free CTG group), masticatory mucosa on the palate between palatal raphae and maxillary posterior teeth is the most common location for the donor site for free CTG. It will be obtained by harvesting and de-epithelializing FGG asbeing a CTG derived from de-epithelialization of FGG mainly composed of lamina propria. Then the donor site will be covered by gel foam , sutured and protected. | Procedure or surgery | Group II (free CTG group): |
| acellular dermal matrix* For the third group (ADM group) , The matrix will be trimmed so that it is gently adapted to the artificial envelope created on the buccal aspect of the ridge.The matrix will be trimmed and beveled to make its adaptation into the artificial envelope easier. Before placement, matrix will be hydrated for 10 minutes in fresh human blood collected after flap elevation in each patient. * For both second and third groups, graft will be carefully positioned under the buccal pouch, sutured to it, light pressure will be applied over the inserted graft with moist gauze for 10 minutes to minimize blood clot and dead space formation between the graft and the underlying bone. | Procedure or surgery | Group III (ADM group): |
| control grouponly placement of dental implant without soft tissue augmentation | Procedure or surgery | Group IV (control group): |
Primary outcome
Clinical measurement of soft tissue thickness
Time frame: 6 months
At the baseline surgical visit, after local anesthetic administeration, the buccal peri-implant mucosal thickness (PMT) will be measured and recorded. An endodontic spreader will be gently inserted through the the surface of the mucosa to the bone, then the thickness measured by the spreader will be recorded using a digital caliper. The procedure will be reapeated after complete healing of the tissue
Esthetic evaluation
Time frame: 6 months
According to Furhauser et al., 2005, esthetic scoring index called pink esthetic score (PES) index will be used in the current study. Seven points of evaluation (mesial papilla, distal papilla, soft tissue margins, soft tissue contouring, alveolar process, soft tissue color and soft tissue texture) of score 0,1,2: this index uses a maximum score of 14, representing optimum esthetic outcome with respect to the peri-implant soft tissue conditions. The PES index fulfilled important characteristics as inclusion of the peri-implant soft tissue and the restoration-inherent parameters.
2 secondary outcomes
modified gingival index
Time frame: 6 months
modified plaque index
Time frame: 6 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 28 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Soft Tissue Augmentation Around Dental Implants
Not yet recruiting
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants
Not yet recruiting
Assessment of Two Soft Tissue Augmentation Using Acellular Dermis Around Dental Implants
Acellular Dermal Matrix, Alveolar Mucosa
Recruiting
CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue
Active, not recruiting
Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
Missing Teeth
Recruiting
Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant Placement
Peri-implant Soft Tissue Deficiency, Partial Edentulism
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.
Ghada A. Elhusseiny, PHD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing buccal pedicle flap, connective tissue graft and acellular dermal matrix in people with Soft Tissue Augmentation Around Dental Implants, run by Ghada Elhusseiny 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 7 inclusion and 3 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 28 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical measurement of soft tissue thickness (time frame: 6 months). The study lists 2 primary outcomes in all. 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 28 Jun 2024.