Soft Tissue Augmentation Clinical Trial
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.
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.
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