Ridge DeficencyNCT03882216
Pontic Site Development With Connective Tissue Graft Using Modified Pouch Technique Versus Pouch Technique
A study testing soft tissue augmentation using pouch technique and soft tissue augmentation using modified pouch technique in people with Ridge Deficency and Soft Tissue Augmentation, run by Cairo University.
Trial summary
The study will be formed on two groups : the control group and the test group For both groups base line impressions will be taken before the surgery and a free gingival graft will be harvested from the palate and deepithelialized to obtain the free connective tissue graft then In the control group: the free connective… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ridge Deficency, Soft Tissue Augmentation
- What is being tested?
- soft tissue augmentation using pouch technique and soft tissue augmentation using modified pouch technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2019to 31 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Missing single tooth loss in anterior and premolar region.
- Seibert Class I ridge defect.
- Systemically free patients.
- The healing period after the tooth extraction had to be at least 3 months prior to the surgical procedures.
Who cannot join
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Severe gagging reflex
About this study
Official title: Clinical Comparison of Pontic Site Development With Connective Tissue Graft Using Modified Pouch Technique Versus Pouch Technique: A Randomized Controlled Clinical Trial
The study will be formed on two groups : the control group and the test group For both groups base line impressions will be taken before the surgery and a free gingival graft will be harvested from the palate and deepithelialized to obtain the free connective tissue graft then In the control group: the free connective tissue graft will be inserted through crestal pouch previously prepared using split thickness flap.
In the test group The free connective tissue graft will be slided through apical vertical incision in the pontic area previously tunneled.
Post operative casts will be obtained by taking impressions after three months and six months to evaluate the volumetric changes in the pontic area.
Read the detailed description
Study settings: Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt. Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University Pre-surgical phase: Patients will be initially examined. All patients received oral hygiene instructions, and non-surgical periodontal treatment will be performed if necessary. At baseline, clinical periodontal measurements including plaque Index, bleeding on probing (BOP) , probing depth (PD) and clinical attachment level (CAL) will be recorded at teeth adjacent to the gap using a Williams's periodontal probe. Impressions will be taken using high viscosity impression material. Models will be cast in dental stone and used as the baseline reference for volumetric measurements. De-epithelialized connective tissue harvesting: The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques ). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection. The graft will then be de-epithelialized, and the connective tissue graft will be used. Surgical site preparation for either control or intervention group: 1- Local anesthesia (2% lidocaine, 1: 100 000 epinephrine), incisions will be placed over the crest of the ridge reaching to alveolar bone. 2- Papillae will include in the incision line only when there is a loss of papillary height. 3- A deep supraperiosteal soft tissue pouch will be prepared by sharp dissection extending apically to the mucogingival line and to the neighboring teeth mesio-distally. 4- A rectangular shaped free gingival graft will be harvested from the contralateral palate using split thickness dissection.
Control group: -The graft will be de-epithelialized and the connective tissue graft will be inserted into the pouch that will be previously prepared at the recipient site and will be secured with two non-resorbable sutures at the labial and the palatal aspect. - Provisional restoration will be temporary cemented. -. Patient will be recalled after 14 days for suture removal.
Test group: Modified pouch technique -. De-epithelialization of the area that resembles in position and size the emergence profile of the pontic -. Tunnel preparation in the soft tissues buccal to the defect region using split thickness flap preparation. - Preparation of the pouch extends in a lateral direction to adjacent teeth and in an apical direction beyond the mucogingival line in order to ensure sufficient flap mobility. -. Flap preparation will also include elevation of the interproximal tissues lateral to the edentulous site. - Vertical releasing incision in the alveolar mucosa apical and distant to the defect will be done. -. The graft will be then drawn using positioning sutures. -. Provisional restoration will be temporary cemented on both abutments then double-crossed sutures are used for the fixation of the buccal soft-tissue complex, including the connective tissue graft. 8. Patient will be recalled after 14 days for suture removal. After the surgical volume augmentation procedure, clinical periodontal measurements will be recorded, impressions will be retaken and models will be cast at 3 and 6 months postoperative, In both control and intervention groups.
- Conditions
- Ridge Deficency, Soft Tissue Augmentation
- Being tested
- soft tissue augmentation using pouch technique, soft tissue augmentation using modified pouch technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue augmentation using pouch techniqueProcedure or surgery
crestal incision with split thickness flap without vertical releasing incision till the mucogingival line then apply the harvested connective tissue graft through it.
soft tissue augmentation using modified pouch techniqueProcedure or surgery
tunneling will be done at the pontic site till the mucogingival line then a distant vertical incision near the tunnel at the lining mucosa where the harvested connective tissue graft wll be applied .
| Study group | Role | What they receive |
|---|---|---|
| test group pouch technique | Experimental | free connective tissue graft augmentation using pouch technique Receives: Procedure: soft tissue augmentation using pouch technique |
| test group modified pouch technique | Experimental | free connective tissue graft augmentation using modified pouch technique Receives: Procedure: soft tissue augmentation using modified pouch technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
volumetric changes at the pontic site
To evaluate the volumetric changes between the baseline and 6 months postoperatively all the cast stone models will be digitized using lab based optical scannerDigital cast models will be reproduced resembling different time points during treatmentSuperimposing the different models of the same case using the best fit algorithm by taking the tooth surfaces as references The area of pontic site will be defined by the mesial and distal papillary midline, the mucogingival line, and the alveolar crest So any volumetric changes between digitalized superimposed casts can be measured.
Measured: 6 months
Secondary outcomes (1)
Postoperative pain - through Visual Analogue Scale
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10. 0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain) VAS will be recorded at day 14
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Jun 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge DeficencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Abdle Aziz Ammar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882216
- Sponsor's protocol ID
- 5111987
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2019
- Last updated
- 20 Mar 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 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Pontic Site Development With Connective Tissue Graft Using Modified Pouch Technique Versus Pouch Technique: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03882216
- Acronym / sponsor ID
- 5111987
- Conditions
- Ridge Deficency, Soft Tissue Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Mar 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.
The study will be formed on two groups : the control group and the test group For both groups base line impressions will be taken before the surgery and a free gingival graft will be harvested from the palate and deepithelialized to obtain the free connective tissue graft then In the control group: the free connective tissue graft will be inserted through crestal pouch previously prepared using split thickness flap.
In the test group The free connective tissue graft will be slided through apical vertical incision in the pontic area previously tunneled.
Post operative casts will be obtained by taking impressions after three months and six months to evaluate the volumetric changes in the pontic area.
Detailed description
Study settings: Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt. Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University Pre-surgical phase: Patients will be initially examined. All patients received oral hygiene instructions, and non-surgical periodontal treatment will be performed if necessary. At baseline, clinical periodontal measurements including plaque Index, bleeding on probing (BOP) , probing depth (PD) and clinical attachment level (CAL) will be recorded at teeth adjacent to the gap using a Williams's periodontal probe. Impressions will be taken using high viscosity impression material. Models will be cast in dental stone and used as the baseline reference for volumetric measurements. De-epithelialized connective tissue harvesting: The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques ). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection. The graft will then be de-epithelialized, and the connective tissue graft will be used. Surgical site preparation for either control or intervention group: 1- Local anesthesia (2% lidocaine, 1: 100 000 epinephrine), incisions will be placed over the crest of the ridge reaching to alveolar bone. 2- Papillae will include in the incision line only when there is a loss of papillary height. 3- A deep supraperiosteal soft tissue pouch will be prepared by sharp dissection extending apically to the mucogingival line and to the neighboring teeth mesio-distally. 4- A rectangular shaped free gingival graft will be harvested from the contralateral palate using split thickness dissection.
Control group: -The graft will be de-epithelialized and the connective tissue graft will be inserted into the pouch that will be previously prepared at the recipient site and will be secured with two non-resorbable sutures at the labial and the palatal aspect. - Provisional restoration will be temporary cemented. -. Patient will be recalled after 14 days for suture removal.
Test group: Modified pouch technique -. De-epithelialization of the area that resembles in position and size the emergence profile of the pontic -. Tunnel preparation in the soft tissues buccal to the defect region using split thickness flap preparation. - Preparation of the pouch extends in a lateral direction to adjacent teeth and in an apical direction beyond the mucogingival line in order to ensure sufficient flap mobility. -. Flap preparation will also include elevation of the interproximal tissues lateral to the edentulous site. - Vertical releasing incision in the alveolar mucosa apical and distant to the defect will be done. -. The graft will be then drawn using positioning sutures. -. Provisional restoration will be temporary cemented on both abutments then double-crossed sutures are used for the fixation of the buccal soft-tissue complex, including the connective tissue graft. 8. Patient will be recalled after 14 days for suture removal. After the surgical volume augmentation procedure, clinical periodontal measurements will be recorded, impressions will be retaken and models will be cast at 3 and 6 months postoperative, In both control and intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group pouch technique | Experimental | Procedure: soft tissue augmentation using pouch techniquefree connective tissue graft augmentation using pouch technique |
| test group modified pouch technique | Experimental | Procedure: soft tissue augmentation using modified pouch techniquefree connective tissue graft augmentation using modified pouch technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Missing single tooth loss in anterior and premolar region.
- Seibert Class I ridge defect.
- Systemically free patients.
- The healing period after the tooth extraction had to be at least 3 months prior to the surgical procedures.
Key exclusion criteria (4 listed)
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Severe gagging reflex
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 |
|---|---|---|
| soft tissue augmentation using pouch techniquecrestal incision with split thickness flap without vertical releasing incision till the mucogingival line then apply the harvested connective tissue graft through it. | Procedure or surgery | test group pouch technique |
| soft tissue augmentation using modified pouch techniquetunneling will be done at the pontic site till the mucogingival line then a distant vertical incision near the tunnel at the lining mucosa where the harvested connective tissue graft wll be applied . | Procedure or surgery | test group modified pouch technique |
Primary outcome
volumetric changes at the pontic site
Time frame: 6 months
To evaluate the volumetric changes between the baseline and 6 months postoperatively all the cast stone models will be digitized using lab based optical scannerDigital cast models will be reproduced resembling different time points during treatmentSuperimposing the different models of the same case using the best fit algorithm by taking the tooth surfaces as references The area of pontic site will be defined by the mesial and distal papillary midline, the mucogingival line, and the alveolar crest So any volumetric changes between digitalized superimposed casts can be measured.
1 secondary outcome
Postoperative pain - through Visual Analogue Scale
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue augmentation using pouch technique and soft tissue augmentation using modified pouch technique in people with Ridge Deficency and Soft Tissue Augmentation, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
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?
volumetric changes at the pontic site (time frame: 6 months). 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 20 Mar 2019.